S1162 A Comparison of Technical Failures and Patient-Related Adverse Events Associated With Three Widely Used Mechanical Lithotripters for ERCP: Insights From the FDA MAUDE Database

Abstract

Introduction: Mechanical lithotripsy is a commonly used, effective method for fragmenting large biliary or pancreatic duct stones. Real-world data on the most commonly reported complications and modes of failure associated with mechanical lithotripters are limited. We analyzed the post-marketing surveillance data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database for three commercially available mechanical lithotripters for use during ERCP. Methods: A search of the FDA MAUDE database from January 2010 to October 2021 was conducted for the the following mechanical lithotripters: Trapezoid RX (Boston Scientific, Natick, MA), LithoCrush (Olympus Endoscopy, Center Valley, PA), and the Fusion Lithotripsy Extraction Basket (Cook Endoscopy, Winston Salem NC). Results were compiled and reviewed. Results: 1,128 medical device reports with 2,129 device malfunctions and 205 patient complications were identified. Most device malfunctions were due to guidewire port or sheath failure (n=379, 17.8%), basket entrapment (n=357, 16.8%), and basket tip separation failure (n=315, 14.8%). The most commonly reported adverse events to patients were an additional procedure to remove an entrapped basket (n=170/205, 82.9%), bleeding (n=15/205, 7.3%), and bowel perforation (n=5/205, 2.4%). Conclusion: Findings from the MAUDE database highlight device and patient-related adverse outcomes that should be recognized to improve clinical success and reduce patient risk.