RX LOCKING DEVICE AND BIOPSY CAP

Additional Manufacturer Narrative

BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF THE SPONGE DETACHED.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WAS USED FOR COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPONGE FROM THE BIOPSY CAP AND LOCKING DEVICE ENTERED THE SCOPE CHANNEL. THE DETACHED PIECE WAS EXTRACTED DURING MANUAL CLEANING. THE PROCEDURE WAS COMPLETED USING A NEW ENDOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.