Comparison of technical failures and patient-related adverse events associated with 3 widely used mechanical lithotripters for ERCP: insights from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database

Abstract

Mechanical lithotripsy is a commonly used, effective method for fragmenting large biliary or pancreatic duct stones. Real-world data on the most commonly reported adverse events and modes of failure associated with mechanical lithotripters are limited. We analyzed the postmarketing surveillance data from the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database for 3 commercially available mechanical lithotripters for use during ERCP. A search of the MAUDE database from January 2010 to October 2021 was conducted for the following mechanical lithotripters: Trapezoid RX (Boston Scientific, Natick, Mass, USA), LithoCrush (Olympus Endoscopy, Center Valley, Pa, USA), and the Fusion Lithotripsy Extraction Basket (Cook Endoscopy, Winston Salem, NC, USA). Results were compiled and reviewed. In total, 1128 medical device reports with 2129 device malfunctions and 205 patient adverse events were identified. Most device malfunctions were because of 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 (170/205, 82.9%), bleeding (15/205, 7.3%), and bowel perforation (5/205, 2.4%). Findings from the MAUDE database highlight device- and patient-related adverse outcomes that should be recognized to improve clinical success and reduce patient risk.