RX LOCKING DEVICE

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026, TO TREAT CHOLANGITIS. DURING THE PROCEDURE, A SPHINCTERTOME DEVICE WAS ADVANCED THROUGH THE WORKING CHANNEL, AT WHICH POINT THE SPONGE BECAME DISLODGED AND LODGED WITHIN THE CHANNEL. THIS OBSTRUCTION PREVENTED ADDITIONAL DEVICES FROM BEING PASSED THROUGH THE WORKING CHANNEL. THE SPONGE WAS SUBSEQUENTLY RETRIEVED USING A BRUSH. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT SCOPE AND A NEW RX LOCKING DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

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 E1: (B)(6). BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF THE SPONGE DETACHED. BLOCK H11: INVESTIGATION RESULTS THE PRODUCT WAS NOT RETURNED FOR EVALUATION TO DETERMINE WHETHER A DEVICE DEFECT WAS PRESENT. THEREFORE, NO ANALYSIS COULD BE CONDUCTED, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. BASED ON THE EVENT DESCRIPTION AND THE INFORMATION PROVIDED BY THE CUSTOMER, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE WHETHER THE SPONGE DETACHMENT FROM THE DEVICE OR DEVICE COMPONENT RESULTED FROM PHYSICIAN TECHNIQUE DURING THE PROCEDURE OR FROM A DEVICE MALFUNCTION. THEREFORE, UNABLE TO EXCLUDE DEVICE PROBLEM HAS BEEN SELECTED AS THE MOST PROBABLE CAUSE FOR THIS EVENT.