ENDOVIVE SAFETY PEG KIT

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE SAFETY PEG KIT PULL METHOD WAS ATTEMPTED TO BE USED IN THE STOMACH DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE SPECIFIC DATE IS UNKNOWN. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PEG TUBE AND THE WIRE LOOP (WHILE ATTACHED TO THE PEG TUBE) COMPLETELY SNAPPED OFF WHEN THE PHYSICIAN WAS TRYING TO PULL THE PEG TUBE THROUGH THE INCISION. THE PHYSICIAN ATTEMPTED TO USE A HEMOSTAT TO PULL THE PART OF THE TUBE STILL COMING OUT OF THE PATIENT AND THE REST OF THE WIRE BROKE OFF. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE LOOP WIRE WAS BROKEN AND WAS DETACHED FROM THE CONNECTING WIRE. IT WAS REPORTED THAT NO PART OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY PEG KIT PULL METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

BLOCK B3: APPROXIMATED BASED ON THE REPORTED EVENT DATE OF (B)(6) 2025. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF LOOP WIRE BREAK. IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF PULL WIRE BREAK.