SPYGLASS RETRIEVAL BASKET

Additional Manufacturer Narrative

BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGERY PERFORMED TO CUT THE STENT AND THE SCOPE OUT OF THE PATIENT. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF PROLONGED HOSPITALIZATION AS THE PATIENT WAS ADMITTED BEYOND THE STANDARD OF CARE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY BASKET WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A SPY BASKET WAS USED TO RETRIEVE A PLASTIC STENT THAT HAD MIGRATED PROXIMALLY INTO THE CBD. THE BASKET WAS ABLE TO GO AROUND THE DISTAL FLANGE ON THE STENT; HOWEVER, IT COULD NOT BE PULLED OUT OF THE DUCT. WHILE THE PHYSICIAN WAS PULLING, THE BASKET WIRES BROKE AND WRAPPED AROUND THE ELEVATOR OF THE ERCP SCOPE. THE STENT WAS STUCK IN THE CBD, THE BASKET WAS STUCK ON THE STENT, AND THE SCOPE WAS STUCK TO THE BASKET. THEREFORE, THE PATIENT HAD AN EXPLORATORY LAPAROSCOPY FOR STENT REMOVAL AND TO CUT THE SCOPE FREE FROM THE STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE HOWEVER, THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.