SPYGLASS RETRIEVAL BASKET

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYBASKET WAS USED IN THE COMMON BILE DUCT DURING A LAPAROSCOPIC CHOLECYSTECTOMY WITH COMMON BILE DUCT EXPLORATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING A PROCEDURE, A SPYGLASS RETRIEVAL BASKET WAS USED TO CAPTURE A LARGE STONE IN THE COMMON BILE DUCT. HOWEVER, WHEN THE BASKET WAS CLOSED, THE WIRE OF THE BASKET BROKE LEAVING THE STONE TRAPPED INSIDE. FURTHER INCISION ON THE PATIENT'S COMMON BILE DUCT WAS PERFORMED IN ORDER TO EXTRACT THE BROKEN BASKET AND STONE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

D3: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK. IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF FURTHER INCISION ON THE PATIENT'S COMMON BILE DUCT WAS PERFORMED IN ORDER TO EXTRACT THE BROKEN BASKET AND STONE.