SPYGLASS DIRECT VISUALIZATION SYSTEM

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORTS # 3005099803-2013-07518 AND 3005099803-2013-07519 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER AND SPYGLASS DIRECT VISUALIZATION PROBE WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) WITH STONE EXTRACTION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A LARGE STONE AT THE DISTAL DUCT WITH A DIVERTICULUM AT THE AMPULLA. THE PHYSICIAN CANNULATED THROUGH THE COMMON BILE DUCT (CBD) WITH THE SPYSCOPE DELIVERY CATHETER AND LOCATED THE STONE. THE PHYSICIAN INSERTED THE SPYGLASS VISUALIZATION PROBE AND A HOLMIUM LASER THROUGH THE SPYSCOPE DELIVERY CATHETER AT THE DISTAL DUCT. WHILE TRYING TO GET A GOOD VISUALIZATION OF THE STONE, THE PHYSICIAN PERFORATED THE DUODENAL DIVERTICULUM. IT IS UNKNOWN WHICH DEVICE CAUSED THE PERFORATION, HOWEVER, ACCORDING TO THE PHYSICIAN THE PATIENT¿S ANATOMY MAY HAVE CONTRIBUTED TO THE EVENT. UPON FLUOROSCOPY AIR WAS SEEN AND THE PHYSICIAN PERFORMED A SPHINCTEROPLASTY. THE STONE WAS EXTRACTED USING A RETRIEVAL BALLOON AND AN ADVANIX STENT WAS PLACED. A NASOGASTRIC TUBE WAS SECURED ON THE PATIENT AND THE PATIENT WAS KEPT OVERNIGHT FOR MONITORING. THE PATIENT'S CONDITION WAS REPORTED AS BEING FINE.

Additional Manufacturer Narrative

THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. ALTHOUGH THE PATIENT¿S EXACT WEIGHT IS UNKNOWN, IT WAS REPORTED SHE IS OVER (B)(6). ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.