SPYGLASS DIRECT VISUALIZATION PROBE

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2009-03810 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER AND A SPYGLASS DIRECT VISUALIZATION PROBE WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) WITH ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROCEDURE PERFORMED IN 2009. ACCORDING TO THE COMPLAINANT, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE SPYPROBE THROUGH THE SPYSCOPE. THE SPYPROBE APPEARED TO BECOME STUCK AT THE SPYSCOPE TIP. THE SPYSCOPE WAS REMOVED FROM THE PATIENT, BUT THE SPYPROBE STILL COULD NOT BE ADVANCED THROUGH THE CHANNEL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. HOWEVER, A BILIARY STENT WAS PLACED TO ALLOW DUCT DRAINAGE UNTIL THE PROCEDURE COULD BE RE-SCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

Additional Manufacturer Narrative

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE SERIAL NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. 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.