Analysis of Reported Adverse Events Associated with Sphincterotomes: An FDA Manufacturer and User Facility Device Experience (MAUDE) Database Study.

BACKGROUND

Sphincterotomes are widely used during endoscopic retrograde cholangiopancreatography (ERCP) for duct cannulation and sphincterotomy. ERCP can be associated with various adverse events (AEs); however, those associated with sphincterotome device problems are not well known. We aim to analyze device problems and patient-related AEs associated with sphincterotomes using the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.

METHODS

After a comprehensive search, we analyzed the post-marketing surveillance data for sphincterotomes from the FDA's MAUDE database to report device-related deaths, injuries, and modes of failure from January 2014 to September 2024. Data related to manufacturers, device problems, and patient outcomes was collected, and descriptive statistics were performed to summarize findings. Report trends over time analysis was also performed.

RESULTS

3909 reports of events related to sphincterotome use were found through September 2024. Total reports by major manufacturers include Boston Scientific (Natick, MA, USA): 44% (1721/3909), Cook Endoscopy (Winston Salem, NC, USA): 22.7% (887/3909), and Olympus (Center Valley, PA, USA): 33.3% 1301/3909. The most common event was malfunction in 94.7% (3701/3909) followed by injury in 5.1% (200/3909) and death in 0.2% (8/3909). The most common device problem was break in 59.8% (2339/3909). A total of 248 patient-related AEs were identified with the most common being foreign body in patients (n = 61, 24.6%) followed by hemorrhage (n = 55, 22.2%), perforation (n = 44, 16.5%), and pancreatitis (n = 40, 16.1%). There was a positive trend of reports years between 2014 and 2021 with p < 0.001.

CONCLUSION

Based on post-marketing surveillance data from the FDA's MAUDE database, our analysis of sphincterotome reports suggests that mechanical failure, particularly device breakage is the most prevalent device problem, and foreign body was the most common patient-related AE. While reported adverse events appear to increase over time, this may reflect increased sphincterotome utilization/procedure volume or reporting vigilance rather than true increases in device-related complications.