Manufacturing Experience Research Articles

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.

15 Industry Perspective on the Value and Challenges of Amino Acid Feeding in Ruminants

Abstract The focus of this presentation is to provide a perspective on the value and challenges to meeting the amino acid needs of ruminant livestock based on experiences in the feed manufacturing and ruminant feeding industries. Monogastric nutritionists have demonstrated extensively the value of having an ideal amino acid profile from the point of growth, efficiency, and environmental stewardship. For the ruminant animal, the challenges of protein fractionation, deamination and re-synthesis of amino acids in the rumen create greater complexity both for research advancement as well as practical application to delivery of amino acid technology. In this presentation, amino acid supplies, protein synthesis, the impact of overlaid growth-promoting technologies, and return relative to investment of amino acid-feeding technology will be discussed. In addition to discussing the biological and economic aspects of amino acid feeding, thoughts on the means of delivering amino acid technology within the constraints of feed manufacturing and feeding practices common to ruminant livestock will be discussed. As genetics for improved lean growth in cattle continue to evolve, amino acid nutrition should be at the forefront of investigation of nutritional technologies which allow the improvement in genetic potential to be fully expressed. In addition to the potential value that amino acid feeding brings to ruminant livestock growth and efficiency, it also stands to merit environmental stewardship within this industry.

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.

Green shared vision: A bridge between responsible leadership and green behavior under individual green values

The pressure on businesses to be environmentally conscious and focus on sustainable development is accruing due to environmental challenges. Companies are adopting ecological practices and policies to improve their environmentally friendly performance. To achieve this, organizations must substantiate and change the behavior of workers to align their behavior with the organization's ecological objectives. The study endeavors to integrate research on the responsible style of leaders and green behaviors of employees (in-role and extra-role green behaviors) through the mediation of green shared vision and analyze the moderation mechanism of individual green values. For collecting the data, a questionnaire-based survey was conducted among MBA executive program students with at least a year of experience in manufacturing. Out of the 450 questionnaires distributed, only 307 useful responses were obtained. The collected data has been analyzed using SPSS and AMOS. Ethical standards were followed, and participants were assured that their responses would be confidential. The study found that responsible leadership positively impacts green behaviors among employees. This means that when leaders within an organization demonstrate responsible and environmentally conscious behavior, it tends to encourage employees to engage in green behaviors. The study also discovered that a “green shared vision” partially mediates the relationship between responsible leadership and in-role green behavior. In contrast, green shared vision does not mediate the relation between responsible leadership and extra role green behavior. Moreover, this study also finds that the relationship between green shared vision and in-role and extra-role green behavior is strengthened when individual green values moderate it. The study highlights the importance of responsible leadership and the role of green shared values and individual green values in promoting environmentally friendly behavior in the workplace.

Assessing the Manufacturability of Students’ Early-Stage Designs Based on Previous Experience With Traditional Manufacturing and Additive Manufacturing

Abstract As additive manufacturing (AM) usage increases, designers who wish to maximize AM’s potential must reconsider the traditional manufacturing (TM) axioms they may be more familiar with. While research has previously investigated the potential influences that can affect the designs produced in concept generation, little research has been done explicitly targeting the manufacturability of early-stage concepts and how previous experience and the presenting of priming content in manufacturing affect these concepts. The research in this paper addresses this gap in knowledge, specifically targeting differences in concept generation due to designer experience and presenting design for traditional manufacturing (DFTM) and design for additive manufacturing (DFAM) axioms. To understand how designers approach design creation early in the design process and investigate potential influential factors, participants in this study were asked to complete a design challenge centered on concept generation. Before this design challenge, a randomized subset of these participants received priming content on DFTM and DFAM considerations. These participants’ final designs were evaluated for both traditional manufacturability and additive manufacturability and compared against the final designs produced by participants who did not receive the priming content. Results show that students with low manufacturing experience levels create designs that are more naturally suited for TM. Additionally, as designers’ manufacturing experience levels increase, there is an increase in the number of designs more naturally suited for AM. This correlates with a higher self-reported use of DFAM axioms in the evaluation of these designs. These results suggest that students with high manufacturing experience levels rely on their previous experience when it comes to creating a design for either manufacturing process. Lastly, while the manufacturing priming content significantly influenced the traditional manufacturability of the designs, the priming content did not increase the number of self-reported design for manufacturing (DFM) axioms in the designs.

Улучшение точностных характеристик формообразующей оснастки с применением композитных силовых каркасов, полученных с использованием бесконтактной измерительной системы

Aviation industry presents the increased demand to geometric accuracy of a product. Component production from the polymer composite materials is based on obtaining final geometric characteristics of a product, as a result of machining on the precision molding equipment. Experience in manufacture of forming equipment from the polymer composite materials demonstrated that a shell reinforced with walls was most effective both structurally and technologically; and it could be considered as the main design scheme for the forming equipment. One of the critical factors influencing the equipment shape accuracy is connection between the frame and the form-building shell. To increase accuracy in manufacturing the form-building equipment, a method is proposed that involves scanning the backside of the form-building shell and subsequent machining of the composite support frame on a CNC machine based on the scanning results, which allows reducing maximum deviations from the shell theoretical contour. Analyzing results of testing this method showed an increase in the frame contact area with the form-building shell and, as a consequence, the adhesive connection area, which made it possible to increase the equipment service life.

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.

Complications of Novel Radiofrequency Device Use in Rhinology: A MAUDE Analysis.

With the widespread adoption of intranasal radiofrequency (RF) devices, our objective was to report national adverse events (AEs) associated with their use. The Food and Drug Administration's Manufacturer and User Facility Device Experience was queried. A total of 24 device-related AEs were reported, 11 (45.8%) for Celon® (Olympus), 3 (12.5%) for Vivaer® (Aerin), 2 (8.3%) for Neuromark® (Neurent), and 8 (33.3%) for Rhinaer® (Aerin). Seven (63.6%) of the Celon®-related complications were related to tissue necrosis (largely user error-related), but 1 (9.1%) episode of pediatric ocular palsy was also reported. Vivaer® complications included synechiae formation, a mucosal perforation, and a case of empty nose syndrome. Of the posterior nasal nerve ablating devices, 9 of 10 AEs were epistaxes, of which 7 (77.8%) required operative intervention. Surgeons should exercise vigilance and tissue-appropriate device settings when utilizing RF devices. Epistaxis and tissue necrosis may occur, as well as more rare, but devastating, complications.

Respiratory Sensing Lead Malfunction in Upper Airway Stimulation: A Single Institution Report.

Upper airway stimulation (UAS) is an effective treatment for patients with obstructive sleep apnea. The device consists of a stimulating electrode, an internal pulse generator, and a respiratory sensing lead. The purpose of this study is to characterize the incidence of sensing lead malfunction necessitating revision surgery in a high-volume center in conjunction with a review of the FDA Manufacturer and User Facility Device Experience (MAUDE) database reports on adverse events associated with the sensing lead component. Patients age ≥18 implanted with the device were reviewed between July 2017 and June 2022. Those determined to have sensing lead malfunction were analyzed. The FDA MAUDE database was reviewed for reports associated with "Inspire Model 4323 Respiratory" and "Inspire Model 4340 Respiratory" between January 2014 and September 2022. One hundred ninety patients underwent UAS at our institution during the study period and four (2.1%) patients were found to have sensing lead malfunction. Analysis of the MAUDE database revealed 122 reports of adverse events associated with the sensing lead component, with 72% (88/122) of these requiring revision surgery. The most frequently reported adverse event was sensing lead tip separation from lead body, noted in 46% of these reports (56/122). The functionality of the sensing lead component is vital to the integrity of the UAS device and is measurable through waveform analysis. To provide optimal care after device implantation, it is essential to have a comprehensive understanding of the scenarios in which this component fails, the incidence of such events, and appropriate management. 4 Laryngoscope, 134:1479-1484, 2024.

LVPRESSURIZATION SYSTEMS OF PROPELLANT TANKS AND PROSPECTS OF THEIR DEVELOPMENT

The experience of domestic and world rocket manufacturing is considered with interesting from the point of view of the used engineering solutions. Positive and negative sides of the introduced solutions are shown.&#x0D; The basic perspective directions of their development are shown among variety of the considered PSs. To them concern: increase of specific function ability of a pressurant gas; improvement physical-chemical and thermal-mass processes, occurring in a tank; regulation and correlation relation of PS parameters; rational selection of a design of pressurization devices; feature of PS experimental development and modelling. In the whole, their use results to increase of LV energy characteristics.

Adverse events associated with amplatzer left atrial appendage occlusion delivery system: A Food and Drug Administration MAUDE database study.

Dual occlusive closure mechanism (disc and lobe type), Amulet device (Abbott; a second-generation device that has replaced Amplatzer Cardiac Plug) was approved by the Food and Drug Administration (FDA) in August 2021 for percutaneous left atrial appendage occlusion (LAAO). However, real-world safety data on the delivery system (Amplatzer Cardiac Plug and Amplatzer Amulet device) are lacking. We sought to assess the type of adverse events associated with the Amplatzer LAAO delivery system using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. A MAUDE database search was conducted on March 31, 2023, for reports received between February 2013 and March 2023 to capture all adverse events. A total of 59 adverse events were reported, of which 58 were sheath-related events, and one was a wire-related event. The most commonly encountered issue was air embolism (19%, 11 events), followed by sheath thrombosis (13.8%, eight events, two of which were also associated with device thrombosis), kinked sheath (10.3%, six events), and sheath deformation (8.6%, five events). Patient-related adverse events included pericardial effusion requiring pericardiocentesis (22.4%, 13 events), vascular complications (20.7%, 12 events), and device dislodgement (5.2%, three events). LAAO-related adverse events are increasingly being reported using the Amplatzer LAAO delivery sheath. It is anticipated that improvements in device technology, the advent of steerable sheaths, and operator experience will minimize these complications.

Adverse Events Associated With Tracheostomy: A MAUDE Database Analysis.

Tracheotomy is one of the most common procedures. Although tracheostomy complications have been extensively studied, literature related to device complications is scarce. The objective of this study is to describe complications associated with tracheostomies utilizing the Manufacturer and User Facility Device Experience (MAUDE) database. Retrospective cross-sectional study. The US Food and Drug Administration's (FDA) MAUDEdatabase (2015-2020). The FDA's MAUDE database was queried for all reports on adverse events related to tracheostomy from January 1, 2015 to December 31, 2020. A total of 3086 adverse events related to open tracheostomy and 52 related to percutaneous tracheostomy were identified. For open tracheostomy, 2872 (93%), were related to device malfunction, and 214 (7%) consisted of patient-related factors. The most frequently reported device-related adverse event was cuff malfunction, with 1834 (59%) reported events, which includes cuff deflation, pilot balloon malfunction, and cuff inflation line malfunction. The most frequently reported patient-related adverse events were tracheostomy tube obstruction with 67 events (2%). For percutaneous tracheostomy, 38 (73%) events were related to device malfunction, and 14 (27%) were related to patient injury. The most frequently reported adverse events were cuff malfunction (29%), safety ridge malfunction (17%), and bleeding (10%). The MAUDE database is a useful tool that can be utilized to complement existing literature in identifying common and rare adverse events associated with tracheostomy device-related failures, which are mostly reliant on isolated, published case reports.

Device malfunctions with use of EUS–guided fine-needle biopsy devices: Analysis of the MAUDE database

ABSTRACT Background The safety of endoscopic ultrasound–guided tissue acquisition through fine-needle biopsy devices is well-established in clinical trials. The real-world experience of using these devices is not known. The authors analyzed the postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to answer this question. Methods The Food and Drug Administration MAUDE database from January 2012 to June 2022 was accessed to evaluate for device malfunctions and patient-related adverse consequences of these malfunctions. Results There were 344 device-related issues. Most issues were due to detachment or breakage of the device (n = 185 [53.7%]). Seventy-six of the breakages (40.8%) occurred during the procedure, whereas 89 cases (47.8%) occurred while removing the needle from the endoscope. The most common site of tissue biopsy at the time of needle breakage was the pancreas (44 [23.8%]). The common patient-related adverse events were retained foreign body (n = 50 [14.5%]) followed by bleeding (16, 4.6%). Six patients (3.4%) required a second intervention for removal of the retained foreign bodies including surgery in 2 cases. The device breakage damaged the endoscope in 3 cases (1.7%), and there was 1 case of needlestick injury to the nurse. Conclusion The fine-needle biopsy devices can be associated with needle breakage and bending; these adverse events were not previously reported. Needle breakages can result in a retained foreign body that may require additional procedures including surgery. These real-world findings from the MAUDE database may inform clinical decisions and help improve clinical outcomes.