SPYSCOPE ACCESS AND DELIVERY CATHETER

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 WAS 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.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01451 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER AND SPYGLASS DIRECT VISUALIZATION PROBE WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE SPYGLASS PROBE, SPYSCOPE, AND COOK CANNULA WERE USED TO TREAT A STRICTURE IN THE COMMON BILE DUCT (CBD). THE PROCEDURE WAS COMPLETED WITH THESE DEVICES. HOWEVER, POST PROCEDURE, THE PATIENT HAD PAIN AND UNDERWENT A CT SCAN WHICH REVEALED THE PRESENCE OF A PERFORATION IN THE CBD. A DUODENAL SUTURING WAS PERFORMED AT THE PERFORATED SITE. THE ACCOUNT WAS NOT ABLE TO IDENTIFY WHICH DEVICE CAUSED THE PERFORATION. REPORTEDLY, RESISTANCE WAS ENCOUNTERED WHILE WITHDRAWING THE DEVICES, BUT NO ISSUES WERE VISIBLE WITH THE SPYGLASS PROBE OR SPYSCOPE. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6), 2011, AND HIS CONDITION WAS REPORTED AS BEING FINE.