Manufacturing Devices Research Articles

Comparing adverse events associated with LigaSure and Harmonic devices in head and neck surgery.

To characterize adverse events, provide a safety profile, and understand patient outcomes after complications arising from LigaSure and Harmonic use in the head and neck region. Retrospective analysis of adverse events from the Manufacturer and User Facility Device Experience (MAUDE) between January 2013 and 2023. A total of 158 LigaSure and 159 Harmonic events were extracted. There were significantly more reports of Harmonic device overheating (6.9% vs. 0.6%, p = 0.003) and spontaneous self-activation (4.4% vs. 0%, p = 0.032). Although intra-operative and post-operative complications were similar among both groups, there were significantly more intra-operative bleeding events for LigaSure as compared to Harmonic (8.2% vs. 0.0%, p = 0.001). Understanding technical complications and adverse events attributable to LigaSure and Harmonic devices enables the development of clinically relevant risk mitigation strategies. Surgeons should avoid improper use by remaining vigilant of device functionality and temperature changes.

Leadless pacemaker tine damage and fracture: novel complications of a novel device fixation mechanism

BackgroundLeadless pacemakers represent a paradigm-changing advancement. However, they required innovative and novel device design, including the use of nitinol tines for fixation. ObjectiveWe aimed to understand the potential for fracture in the novel tine-based fixation mechanism. MethodsA retrospective approach was used to search the Manufacturer and User Facility Device Experience (MAUDE) database for events related to Micra pacemaker tine fracture and damage. Review of each report was performed to ascertain frequency of tine fracture and damage. ResultsOf 4241 MAUDE reports (2104 Micra VR, 2167 Micra AV), 230 included the terms “fracture” or “tine”, which yielded 7 tine fractures and 19 reports of tine damage. Overall, 2/7(29%) tine fractures were noted during implant, whereas 2/7(29%) were discovered ≥1 week after implant; 5/7(71%) tine fracture reports described no associated patient signs or symptoms, and 4/7 (57%) described no change in pacing parameters. Tine damage occurred during implant in 16/19 (84%), compared with 2/19 (11%) noted ≥1 week after implant;15/19 (79%) tine damage cases reported no associated signs or symptoms, and 7/19 (37%) described no changes in pacing parameters. Among all cases, there was 1 case of device embolization. ConclusionsThe novel tine-based fixation mechanism appears susceptible to a novel failure mechanism – tine fracture and/or damage. Our analysis suggests these events may not always be associated with adverse signs or symptoms. Diligent attention at implant, and future bench or clinical studies are needed to understand the rate, clinical impact, and mechanism of such failures, and role of surveillance.

Adverse events related to triplanar 1st tarsometatarsal joint arthrodesis: 5-year analysis of the united states food and drug administration manufacturer and user facility device experience database

BackgroundThe Lapiplasty® 3D Bunion Correction™ system represents an instrumented, jig-guided system to facilitate performing triplanar 1st tarsometatarsal joint arthrodesis. Literature available for this system is positive, although the vast majority is from inventor/consultant surgeons. The purpose of this manuscript is to review adverse event submissions recorded in the Manufacturer and User Facility Device Experience database specific to this system. MethodsThe Manufacturer and User Facility Device Experience database was retrospectively reviewed from inception to 30 June 2023 for adverse events submitted for the Lapiplasty® 3D Bunion Correction™ system. Submissions that involved a medical device product other than this system, duplicate entries, and submissions with data extracted from already published literature were excluded. ResultsA total of 180 unique reports that met inclusion criteria during the 5-year period available were reviewed. The mean time between event occurrence and submission was 46.7-days. The most common entity submitting to the database were the manufacturer company representative or distributor in 66.4%. The most frequently encountered patient problems were pain in 41.9%, non-union in 18.2%, and hardware-related irritation in 11.7%. Reports that detailed a revision surgery described partial/complete hardware removal in 62.7% and revision with additional hardware implantation in 23.3%. ConclusionWhile no direct conclusions regarding the Lapiplasty® 3D Bunion Correction™ system can be drawn from the data as it consists of only adverse event reports, this study demonstrates the need for more non-inventor/consultant literature to further investigate adverse events related this particular system.

LARIAT or AtriClip: Complications Profile and Comparison in Patients with Atrial Fibrillations Based on Manufacturer and User Facility Device Experience Database.

Background and Objectives: Left atrial appendage closure is an alternative treatment to reduce thromboembolism in patients with atrial fibrillation in whom oral anticoagulation (OAC) is contraindicated. The aim of this study was to evaluate the complications profiles of the LARIAT and AtriClip devices and perform a comparison between them based on the MAUDE (Manufacturer and User Facility Device Experience) database. Materials and Methods: The Manufacturer and User Facility Device Experience database was searched on 15 January 2023. For AtriClip, only reports regarding isolated procedures or procedures associated with minimally invasive ablation were included. Adverse effects and causes of death were defined based on the literature on the topic and the causes described in the reports. In total, 63 patients were included in the LARIAT group and 53 patients were included in the AtriClip group. Results: With the LARIAT device, the most common complication without device problems was pericardial effusion (n = 18, 52.9%), whereas this complication was not observed with AtriClip (p < 0.001). Postoperative bleeding was a second complication that occurred significantly more often in the LARIAT group-in 15 (44.1%) cases versus 1 (2.7%) case with AtriClip (p < 0.001). In addition, significant differences were found in the prevalence of stroke (LARIAT n = 0 vs. AtriClip n = 7, 18.9%, p = 0.012) and thrombus (LARIAT n = 2, 5.9% vs. n = 11, 29.7%, p = 0.013). Conclusions: Each type of left atrial appendage closure procedure is associated with device-specific requirements and complications that, if known, can be avoided.

Polyether Ether Ketone (PEEK) Implants and the Manufacturer and User Facility Device Experience (MAUDE) Database: An Updated Review of Adverse Events and Complications.

Polyether ether ketone (PEEK) custom implants have been fundamental in addressing bone malformations and restoring traumatic defects within the field of craniofacial surgery. Although such implants are generally considered safe and appropriate alternatives to autologous bone grafts, there has been a lack of standardized reporting of adverse events associated with PEEK implants. The purpose of this study is multi-fold: (1) to explore the current landscape of autologous and allogeneic materials utilized for bone grafting; (2) to analyze and characterize adverse events associated within PEEK implants from the widely accredited, FDA-run database, Manufacturer and User Facility Device Experience (MAUDE); and using the data, (3) to provide guidance to craniofacial surgeons using PEEK implants in their surgical practice. A retrospective review of the adverse events associated with PEEK implants were performed through the FDA-run database, Manufacturer and User Facility Device Experience (MAUDE). The database was surveyed from July 2013 to January 2023. Event types were categorized by injury or malfunction, and device-reported adverse events were recorded, respectively. Database search initially yielded 77 adverse event reports, but after duplicates were removed, 69 event reports were included in the analysis. These events were sorted into the following categories: device-related and patient-related. Event types were categorized by injury (48.3%) or malfunction (53.6%). The most common reported device-related adverse events were "Poor Fit" (53.6%) and "Adverse Event without Identified Use or Problem " (26.1%). The most common reported patient-related event was "Infection" (32.8%). Of these adverse event reports, 14 (20.2%) patients required a second surgery; 21(30.4%) required implant modification whereas in the operating room; 17 (24.6%) underwent implant removal. Nine (13%) patients experienced operative case delays due to implant modifications. Infection and poor fit were among the most commonly reported adverse events associated with PEEK customizable implants. Although PEEK implants have been widely implemented in addressing craniofacial bony defects, our database analysis does call for further investigation in studying the long-term outcomes associated with PEEK craniofacial implants. With such analyses and collaboration among plastic surgeons and device engineers, there is great opportunity for innovation of these devices.

Complications of eustachian tube balloon dilation: Manufacturer and User Facility Device Experience (MAUDE) database analysis and literature review.

To provide an analysis of complications following eustachian tube balloon dilation as well as their treatments and outcomes. PubMed, Ovid Embase, and MAUDE Database. A systematic approach following PRISMA guidelines was used to identify publications pertaining to balloon dilation of the eustachian tube from PubMed and Ovid Embase databases was used. Once these publications were critically reviewed, the primary outcome extracted were reported complications. Additional complications were collected in the Manufacturer and User Facility Device Experience (MAUDE) database using the product class "eustachian tube dilation device" and searching through relevant manufacturers. Complications and outcomes were compared between these sources. Fifty five full-length manuscripts involving 7155 patients were included and 98 complications reported for a 1.4% complication rate. The most frequently reported adverse events were subcutaneous emphysema of the head and neck (19%), epistaxis (12%), and acute otitis media (11%). The MAUDE search returned 18 distinct patient entries, of which 12 (67%) reported complications. The most reported complications in the MAUDE database included subcutaneous emphysema (8, 67%) and pneumomediastinum (3, 25%). The most serious complication was a carotid artery dissection reported in one patient in the MAUDE database. Eustachian tube dilation is rarely associated with complications, which nevertheless may lead to morbidity and medical emergencies. Patients and providers should recognize potential risks associated with this intervention as well as methods to manage complications.

Hybrid ANFIS-PSO algorithm for estimation of the characteristics of porous vacuum preloaded air bearings and comparison performance of the intelligent algorithm with the ANN

Air bearings are commonly used in systems requiring high precision, including semiconductor manufacturing, optical and electronic devices, and aerospace systems, and the usage of vacuum preloading and porous material provides a homogeneous pressure distribution on the bearing surface. The prediction of the characteristics of these air bearings, such as air film thickness and location, is crucial for designing and optimizing the performance of the systems. They exhibit highly nonlinear behavior and are challenging to accurately predict their characteristics using conventional analytical or numerical techniques. In this study, the characteristics of vacuum preloaded porous air bearings are estimated using a hybrid ANFIS-PSO predictor soft computing method with a certain pressure (410 kPa), vacuum (50.8 kPa), and with three different diameters (50, 75 and 90 mm). The usage of different algorithms in the characteristics and selection and design criteria of air bearing has been applied. Six different cases are simulated with different input and output parameters to predict the air film thickness and location of the air bearing. The location of the air bearing has been determined with two angle parameters, α, and β. The dataset required for training and testing the algorithm was obtained through experimental study. In the training and testing process, 40 and 20 datasets were used, respectively. Before the starting analysis, a sensitivity analysis was executed to find optimum PSO parameters such as the number of particles, acceleration coefficients, number of membership functions, and inertia weight. The proposed hybrid ANFIS-PSO method was compared with classical ANFIS and ANN, and it showed better performance and a more accurate solution to estimate the characteristics of vacuum preloaded porous air bearings in both training and testing phases with the R2 of 0.9958 and MSE value of 0.102. The maximum training performance of the ANFIS-PSO is better than ANFIS and ANN with the ratio of 6.8% and 8.5%, respectively. On the other hand, the maximum testing performance of the ANFIS-PSO algorithm is higher than ANFIS and ANN, with the ratio of 22.2% and 24.1%, respectively.

Abstract 15366: Quantification of Recent Reporting Rates of Atrioesophageal Fistula After Left Atrial Ablation for the Treatment of Atrial Fibrillation

Introduction: Atrio-esophageal fistulas (AEF) are a feared and fatal complication of left atrial ablation for the treatment of atrial fibrillation (AF). The recent POTTER-AF survey suggests that AEFs continue to occur despite best efforts to prevent them. A quantification of recent incidence rates and outcomes of AEF reported to the Manufacturer and User Facility Device Experience (MAUDE) database of the U.S. FDA may further elucidate trends in this complication. Research Question(s): What are the recent trends in reporting rates of AEF, and what are the outcomes? Purpose: To quantify the number of AEF reports as well as any reported outcomes of atrioesophageal fistulas and determine any trends over the last 4 years. Methods: We reviewed data from the Manufacturer and User Facility Device Experience (MAUDE) database for complications under the category of fistula that occurred over the last 4 years (2019 to 2022 inclusive). Reports were reviewed for any descriptions of outcome, and narratives were compared in an attempt to identify and exclude any duplicate reporting. Results: In total, three product codes resulted in 121 reported AEFs. Of these, 50 (41%) were listed as fatal. When provided, the time frame of death ranged from 12 days to several weeks after the index procedure. Product codes reporting AEFs included LPB (88 cases), OAE (22 cases), and OAD (11 cases), with codes representing cardiac ablation catheters and radiofrequency generators. Incidence by year showed a generally increasing trend (21 in 2019, 22 in 2020, 41 in 2021, and 37 in 2022, Figure 1). Conclusion: The annual rate of reported AEFs has not decreased over the last 4 years, and instead shows a generally increasing trend. Reported fatality rates remain high at 41%.

Abstract 13319: The Barostim Baroreflex Activation Therapy System: Safety Insights From FDA MAUDE Database

Introduction: BAROSTIM NEO® is a Baroreflex activation therapy (BAT) system which has been approved recently by FDA for patients with refractory heart failure. Post market experience of BAT related complications and performance issues have not been reported. Objective: To analyze the post-approval device failures and patient related adverse events (AE) associated with Barostim NEO® system using Manufacturer and User Facility Device Experience (MAUDE) database. Methods: A MAUDE database search was conducted on December 7, 2022, for reports received between Jan 1, 2019, to November 30, 2022. Manual search of the MAUDE database conducted using the term “Barostim” in the brand name section. The AE were adjudicated to various categories based on the review of the event description for each medical device report (MDR). Results: A total of 22 events were reported which included MDRs reported by physicians or manufacturer or both. Device related malfunction was reported in 45.5% (n=10) whereas patient related AE reported in 77.3% (n=17) cases. Of total device related AE, material split, cut or torn was most commonly reported problem (32%, n=7), followed by high impedance (13.6%, n=3) and low impedance (9.1%, n=2). Of the patient related AE, 32% (n=7) were related to clinical or subclinical infection, 18.2% (n=4) hematoma, 13.6% (n=3) heart failure or myocardial injury, 9.1% (n=2) stroke/CVA, 9.1% and 9.1% (n=2) twiddler’s syndrome. No carotid artery or jugular injury and procedure related death reported in the study period. The report is limited by the lack of information on the total number of BAT devices implanted across the country. Conclusions: This study provides a wide range of device malfunction and patient related post-approval adverse events for Barostim device which have not been reported in any clinical trial/study before. The reported complications seem to be in line with other cardiac implantable electronic devices and no BAT specific complications were noted.

Characterizing complications associated with skull clamps: A review of the manufacturer and user facility device experience database

ObjectiveHead immobilization with skull clamps is a prerequisite of many neurosurgical procedures. Adverse events relating to the use of skull clamps have been reported, however, given the paucity of published reports, we sought to conduct a more comprehensive analysis using the Manufacturer and User Facility Device Experience (MAUDE) database. MethodsThe MAUDE database was queried for neurosurgical skull clamp events over a 10-year period between January 2013 and December 2022. Reports were qualitatively analyzed and categorically assigned by the study authors as ‘mechanical failure,’ ‘slippage,’ ‘contamination,’ ‘insufficient information,’ and ‘other.’ Patient injury reports were also classified as ‘abrasion,’ ‘laceration,’ ‘hematoma,’ ‘fracture,’ ‘intracranial hemorrhage (ICH),’ ‘other,’ ‘insufficient information,’ and ‘death.’ ResultsOf 3672 reports retrieved, 2689 (73.2%) were device malfunctions, with mechanical failure (50.7%) and slippage (47.7%) being the most common causes. There were 983 reports (26.8%) involving patient injury which included lacerations (n = 776, 78.9%), fractures (n = 24, 2.4%), abrasions (n = 23, 2.3%), hematomas (n = 7, 0.71%), ICH (n = 3, 0.31%), and other causes (n = 6, 0.61%). Five (0.1%) deaths due to skull clamp related complications were also reported. ConclusionsThis study provides a more comprehensive picture of adverse events in neurosurgical procedures relating to the use of skull clamps. Mechanical failures of device parts were the most common device-related complication, and lacerations the most common adverse patient-related event. While more severe patient-related events were reported, they are relatively rare. The MAUDE database is useful for characterizing underreported device-related and patient-related adverse events.

Pediatric Airway Balloon Dilation: Urge for Safety Redesign.

Airway balloons are widely used by otolaryngologists to treat laryngotracheal stenosis. We review an adverse event and interventions that may prevent similar occurrences. There are no other reports of similar incidents in the Food and Drug Administration Manufacturer and User Facility Device Experience. We implore Acclarent to redesign their airway balloon device to prevent accidental airway irrigation.

Cost-effective fabrication of customized LTCC devices with multilayer using multi-material 3D printing

Low-temperature co-fired ceramic (LTCC) devices have been widely used in the defense, automotive, medical, and aerospace industries. However, the traditional manufacturing process of LTCC devices is hardly suitable for cost-effective, fast design and customization requirements. In this work, we propose a multi-material integrated 3D printing technology for LTCC. LTCC slurry was configured using homemade borosilicate glass powder and Al2O3 powder, and the influence of printing parameters on the printed effect was investigated. The shrinkage of the ceramics sintered at 850 °C for 15 min was 14.82 ± 0.47 % in the XY direction and 13.7 ± 0.26 % in the Z direction, comparable to that of commercial LTCC. Wireless sensing multilayer LED circuit and passive humidity sensor were fabricated, where the sensor with a sensitivity of 0.132 MHz/%RH. These cases demonstrate that the proposed technology can rapidly produce LTCC devices and meet the demand for custom LTCC devices in high-end manufacturing.

Three-Dimensional Acoustic Assembly Device for Mass Manufacturing of Cell Spheroids.

Cell spheroids are promising three-dimensional (3D) models that have gained wide applications in many biological fields. This protocol presents a method for manufacturing high-quality and high-throughput cell spheroids using a 3D acoustic assembly device through maneuverable procedures. The acoustic assembly device consists of three lead zirconate titanate (PZT) transducers, each arranged in the X/Y/Z plane of a square polymethyl methacrylate (PMMA) chamber. This configuration enables the generation of a 3D dot-array pattern of levitated acoustic nodes (LANs) when three signals are applied. As a result, cells in the gelatin methacryloyl (GelMA) solution can be driven to the LANs, forming uniform cell aggregates in three dimensions. The GelMA solution is then UV-photocured and crosslinked to serve as a scaffold that supports the growth of cell aggregates. Finally, masses of matured spheroids are obtained and retrieved by subsequently dissolving the GelMA scaffolds under mild conditions. The proposed new 3D acoustic cell assembly device will enable the scale-up fabrication of cell spheroids, and even organoids, offering great potential technology in the biological field.

Toward tailoring the mechanical and dielectric properties of short glass fiber‐reinforced epoxy composites

AbstractGlass fiber‐reinforced polymer‐matrix (GFRP) composites are used to manufacture devices such as radomes, electrical insulators, and radar‐absorbing structures, many of which are used in applications with strict mechanical and dielectric property requirements. As such, designs and properties of GFRP composite materials should be regularly improved to guarantee their safe operation and meet their constantly evolving application requirements. In this study, glass fiber (GF) particles and epoxy resin 128 (EP‐128) were used to manufacture high‐performance EP/GF‐X composites with GF particle contents ranging from 5% to 40%. An investigation into their mechanical and dielectric properties revealed that EP/GF‐20 composite specimens presented the best mechanical performance with their bending strength and modulus reaching 159.68 MPa and 6521.92 MPa, respectively, and an average dielectric constant of 4.862 within the 10–105 Hz frequency range. A theoretical analysis of the EP/GF‐X composite specimens' dielectric constants using classic dielectric models based on the Lichtenecker, Bruggeman, Jaysundere‐Smith, and Maxwell‐Garnett rule‐of‐mixture equations indicated that the dielectric model based on the Bruggeman rule‐of‐mixture equation provided the dielectric constants closest to the measured values with a maximum deviation of less than −0.321% for EP/GF‐40 composites. This study provides a feasible strategy to control the mechanical and dielectric properties of GFRP composites.Highlights Glass fiber (GF) particles and epoxy 128 (EP‐128) resin were used to manufacture high‐performance glass fiber‐reinforced epoxy (EP/GF‐X) composites. The composite manufacturing process was carefully controlled to ensure uniform distribution and orientation of GF particles in the EP‐128 resin. The mechanical and dielectric properties of the manufactured EP/GF‐X composites were effectively tailored by controlling the content and distribution of GF particles in the EP‐128 resin matrix. The dielectric constants of the EP/GF‐X composites were measured experimentally and predicted using various theoretical dielectric models. The Bruggeman model provided the dielectric constants of the EP/GF‐X composites closest to the measured values.

Adverse Events of Femtosecond-Assisted Laser-Assisted In situ Keratomileusis: A Manufacturer and User Facility Device Experience Database Study.

To analyze the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices, and characterize the most common adverse events of femtosecond (FS) laser-assisted in situ keratomileusis (LASIK). The MAUDE database was queried on May 19, 2022, for adverse events involving the ophthalmic FS laser reported from January 2012 to April 2022. Reports unrelated to LASIK procedures were excluded. Data extraction was performed on these reports, including the type of adverse event and whether surgery was successfully completed. Frequency analysis was performed using the Statistical Package for the Social Sciences. From the 3491 reported adverse events involving the FS laser system, 1136 met the inclusion criteria. Of the 672 cases where outcomes were reported, 476 were successfully completed and 196 were aborted. The most common intraoperative complications were incomplete cut (42.8%), thinner than intended flap (17.6%), and difficulty lifting the flap (12.0%). FS-related complications included opaque bubble layer (2.3%), air bubbles in the anterior chamber (2.4%), and vertical gas breakthrough (4.1%). Other device-related intraoperative complications included suction loss (10.2%), difficulty docking (2.4%), and laser malfunction (2.0%). The most common postoperative complications were diffuse lamellar keratitis (DLK) (7.8%) and rainbow glare (4.6%). The most common intraoperative FS-assisted LASIK complication in the MAUDE database was an incomplete flap. The most common postoperative complication was DLK. This study is the first to investigate FS-assisted LASIK adverse events in the MAUDE database. It can raise awareness of real-world surgical complications and help ophthalmologists better counsel and treat patients.

Complications Associated with Microdebriders in Otolaryngology Procedures from 2011 to 2021: A MAUDE Study.

The microdebrider is a powered surgical instrument that is widely used in the field of otolaryngology. We aim to identify the type and frequency of device malfunctions, patient complications, and subsequent interventions related to the use of microdebriders. Cross-sectional analysis. The US Food and Drug Administration (FDA) 2011 to 2021 Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database was queried for reports of "microdebrider," with adverse events selected that pertained to usage in head and neck surgeries from January 1, 2011 to December 31, 2021. There were 282 adverse events in 267 individual medical device reports (MDR). Although the majority of the reports did not specify the specific operation, endoscopic sinus surgery was the most common reported procedure (89, 33.3%). The most common cause of device malfunction was due to a broken piece (120, 48.2%) followed by overheating of the microdebrider motor (78, 31.3%). Of the reports which specified patient injury, the most commonly reported was "unintentional tissue damage," (10, 32.3%). The microdebrider has demonstrated utility within the field of otolaryngology, but is not without risk of malfunction that can cause patient injury. By understanding possible risks of microdebrider usage, including tissue damage, burns, and bleeds caused by device malfunction or operator error, physicians can be better prepared to address complications and educate patients.

Adverse Event Reporting of Commonly Used Gender-Specific Implantable Medical Devices in the United States.

Evidence suggests that more women are harmed by implantable medical devices than men. It is unknown whether this difference includes gender-specific devices. In this study, we examine the differences in reported adverse events between 6 female- and 5 male-specific implantable devices from the Manufacturer and User Facility Device Experience (MAUDE) database from 1993 to 2018. Primary endpoints were injury type (life-threatening, disability, death) and the rate of device evaluation by the manufacturer. Proportions of valid entries across these variables were compared using either the Fisher exact test or χ2 test. Female-specific devices had higher rates of life-threatening outcomes (1.6% versus 0.3%, P < 0.001), disabilities (5.0% versus 4.3%, P < 0.001), and deaths (0.6% versus 0.1%, P < 0.001) compared with the male-specific devices. Of the 8159 devices that were evaluated by the manufacturer, 56% were female specific while 44% were male specific. Female-specific devices were evaluated far less frequently by the manufacturer (4.5% versus 38.2%, P < 0.001). Increased adverse events reports for female-specific devices and associated high-grade complications necessitates improved postmarket surveillance.

Nasal Epistaxis Balloons: A Comprehensive MAUDE Database Analysis

BackgroundWhile nasal epistaxis balloons are generally seen as safe and routinely utilized by both surgical and nonsurgical providers, the complication profile related to this type of device has not been well defined. ObjectiveThe objective of this study was to utilize the FDA MAUDE (Manufacturer and User Facility Device Experience) database to better assess adverse events (AE) related to use of nasal epistaxis balloons. Reports were individually tabulated and events were categorized with special attention to AEs. MethodsThe FDA MAUDE database was queried for all medical device reports (MDR) related to nasal epistaxis balloon devices from January 2012 to November 2022. Results19 MDRs met inclusion criteria. 5 MDRs were classified as device related (26.3 %); two events were reported for balloon leak and deflation, two events were reported for device breakage, and one device related event was unknown. 14 MDRs (73.7 %) were classified as patient related. Two documented MDRs were patient deaths due to exsanguination. Additional serious AEs included balloon ingestion and subsequent small bowel perforation (n = 1), cerebrospinal fluid leak (n = 1), skull base violation and intracranial placement of the device (n = 1), and respiratory distress (n = 3). ConclusionThough epistaxis control with nasal balloons is generally seen as a safe procedure, there have been several concerning AEs reported. While two reports of death due to exsanguination were the most severe AEs, multiple other life-threatening AEs were also documented. Increased awareness of associated complications can be used to better counsel patients during the informed consent process as well as providers in their clinical decision making.

Real-World Complications of the SpaceOAR Hydrogel Spacer: A Review of the Manufacturer and User Facility Device Experience Database

To characterize adverse events related to use of the perirectal spacing agent SpaceOAR, we examined the Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database was queried for "SpaceOAR" and "Augmenix" from June 2015 (when SpaceOAR was approved by the Food and Drug Administration) to October 2022. Reports were reviewed for adverse events (AEs), operative procedures performed because of the AE, and changes to the radiation plan. AEs were categorized using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Six hundred fifty-four reports were reviewed. Eighty-four were excluded and 4 reports reviewed 2 separate cases of SpaceOAR administration. Five hundred seventy-four cases were ultimately included. Three deaths were reported (0.5% of all AEs). One point six percent of cases represented CTCAE grade 4 injuries (life-threatening consequences; urgent intervention indicated), 15.9% grade 3 (severe but not immediately life-threatening; hospitalization), 24.2% grade 2 (moderate; local/noninvasive intervention), and 57% of events were CTCAE grade 1 (mild; asymptomatic or mild symptoms). Bowel diversion occurred in 29 cases (9%). Both asymptomatic (n=311) and debilitating (n=12) complications of SpaceOAR hydrogel use were identified. Death, gel embolization, anaphylaxis, rectal ulcerations, and infections requiring bowel or urinary diversions were among the complications reviewed. Providers should consider these potential complications before perirectal spacer administration and during patient counseling.

Insights From the FDA's MAUDE Database Regarding the Real-World Safety of Jetstream Atherectomy for Peripheral Arterial Disease.

Rotational atherectomy has shown promise as an adjunctive therapy to percutaneous transluminal angioplasty (PTA) and stenting for the treatment of peripheral arterial disease (PAD). However, published data regarding the safety of these devices are limited. The Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database collects reports of adverse event for medical devices. We present 3 years of MAUDE adverse events data for the Jetstream Atherectomy System (Boston Scientific) for the treatment of PAD. We searched MAUDE from January 1, 2019 to December 31, 2021. Duplicate reports and those with insufficient information were excluded, leaving a total of 500 reports for analysis. Adverse events were categorized as either patient complication, device malfunction, or both. Adverse events were classified using the Cardiovascular and Interventional Radiological Society of Europe's (CIRSE) classification system for adverse events. The most common patient complications were embolism (22; 4.4%), dissection (17; 3.4%), vessel perforation (12; 2.4%), and device fracture in the patient (6; 1.2%). The most common modes of device failure were entrapment of the device on the guidewire (134; 27%), loss of blade rotation (116; 23%), loss of aspiration (99; 20%), and mechanical damage (57; 11%). As per the CIRSE adverse events classification, most events had no post-procedural sequelae (475; 95%), followed by those requiring prolonged observation (14; 2.8%), and post-procedural therapy without long-term sequelae (10; 2.0%). One hundred six devices (21%) were returned for manufacturer analysis. We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. This analysis provides further understanding of the safety profile and modes of failure of Jetstream, and could help guide improvements in product design and manufacturer-user training. There is greater need for root-cause analysis that can aided by returning devices to the manufacturer. We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. The MAUDE database is useful for capturing and characterizing modes of device failure/malfunction not typically described in conventional clinical studies. This may provide valuable information to help guide improvements in product design and manufacturer-user training. This information could also potentially be useful in helping establish manufacturer and product liability in the setting of medicolegal claims. We hope that by contributing to the growing understanding of the safety profile of the Jetstream Atherectomy System, our study may help physicians and patients come to more informed decisions regarding treatment options for PAD.