Exploring Balloon Sinuplasty Adverse Events With the Innovative OpenFDA Database.

Abstract

Balloon sinuplasty (BSP) has become a common, minimally invasive treatment for chronic sinusitis. Like any surgical procedure, there are definite risks when using it as a stand-alone procedure or in conjunction with other revision procedures. To explore the adverse events of BSP using the openFDA cloud with regard to malfunction and injury following surgery. Between January 2015 and December 2018, the Food and Drug Administration's (FDA) openFDA database was queried for adverse event use. Reports were further categorized by procedure location, injury type, device malfunction, procedure (stand-alone BSP vs hybrid), and source of complication (anatomical or surgeon related). Seventy-eight events were reported to the FDA in the study period. Majority of cases consisted of device malfunctions (64.1%), while patient injuries consisted of 43.5%. Frontal sinus procedures had the greatest presence of adverse events (47.4%) with the majority reporting significant cerebrospinal fluid (CSF) leaks (P < .001) and device retention (P = .021). Orbital complications (P = .004) were found to be significantly associated with dilation of the maxillary sinus. Skull-based injuries were the only factor incident in which surgeon-reported anatomical complications were significant (P = .018). As balloon dilation procedure continues to rise in the United States, significant adverse events continue to occur. Frontal sinus BSP leads to the highest number of complications and a 4.75 reported CSF leaks yearly. Based on real data, surgeons performing the procedure should be acquainted with common BSP-related injuries so they can prepare for those circumstances and share informed consent with their patients.