SPYGLASS DIRECT VISUALIZATION SYSTEM

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. ACCORDING TO THE COMPLAINANT, THE SPYSCOPE WAS USED TO COMPLETE THE PROCEDURE. HOWEVER, FOLLOWING THE ERCP, "A TUBULAR PIECE OF PLASTIC OR RUBBER," APPROXIMATELY 2MM X 7MM IN SIZE AND "WHITE/YELLOW" IN APPEARANCE, WAS RECOVERED FROM THE PATIENT'S COMMON BILE DUCT. THE PHYSICIAN SUSPECTS THAT THE FRAGMENT MAY HAVE ORIGINATED FROM THE SPYSCOPE; HOWEVER, SUBSEQUENT EXAMINATION OF THE DEVICE IDENTIFIED NO DAMAGE. REPORTEDLY, NO MALFUNCTION OF THE SPYSCOPE OCCURRED. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

CONCOMITANT MEDICAL DEVICE: OLYMPUS SCOPE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. THE COMPLAINANT INDICATED THAT THE DEVICE 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. (B)(4).