SPYGLASS DIRECT VISUALIZATION SYSTEM

Description of Event or Problem

ADDITIONAL INFORMATION: THE SPYSCOPE WITH PRELOADED EHL PROBE WAS BACKLOADED OVER A GUIDEWIRE DURING REINTRODUCTION INTO THE PATIENT. REPORTEDLY, THE EHL PROBE WAS NOT HELD IN PLACE WHILE BACKLOADING THE SPYSCOPE. ADDITIONALLY, THE SEVERITY OF THE EHL PROBE PROTRUDING FROM THE SPYSCOPE IS UNKNOWN.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS & DELIVERY CATHETER WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE EHL PROBE WAS NOT ABLE TO BE ADVANCED THROUGH THE SPYSCOPE IN THE COMMON BILE DUCT. THE PROBE AND SPYSCOPE WERE REMOVED, THEN THE EHL PROBE WAS PRELOADED TO THE DISTAL TIP OF THE SPYSCOPE. THE PRELOADED SPYSCOPE WAS THEN ADVANCED THROUGH THE ERCP SCOPE AND INTO THE BILE DUCT. HOWEVER, AT THIS TIME, A PERFORATION TO THE COMMON BILE DUCT WAS OBSERVED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT TO SURGERY TO REPAIR THE PERFORATION. ADDITIONALLY, THE USER NOTED THAT A TUMOR WAS FOUND AND REMOVED WHEN THE PATIENT WAS SENT TO SURGERY. THE PATIENT'S CONDITION WAS REPORTED AS BEING FINE.

Additional Manufacturer Narrative

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.