BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX¿ BILIARY

    MDR report key: 2853144 · Received November 30, 2012

    Report

    Report Number
    3005099803-2012-05382
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    September 21, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) GUIDE CATHETER BROKEN AND THE INVESTIGATION REVEALED EVENT OF PUSH CATHETER BROKEN. A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE DELIVERY SYSTEM WAS RETURNED WITH THE STENT DEPLOYED. THE PULL WIRE WAS FULLY RETRACTED AND THE PULL WIRE HUB HAD SEPARATED AND WAS RETURNED. THE GUIDE CATHETER WAS SEPARATED FROM THE PULL WIRE CANNULA. THE PULL WIRE CANNULA WAS RETRACTED PAST THE BLUE PORTION OF THE PUSH CATHETER AND TORE THE SIDE WALL OF THE WHITE PORTION OF THE PUSH CATHETER. THE NOTED DAMAGES INDICATE DIFFICULTY WAS EXPERIENCED DURING DEPLOYMENT AND ARE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PRELOADED BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE PANCREATIC DUCT PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY DEPLOY THE STENT; HOWEVER, THE GUIDE CATHETER BROKE AND REMAINED IN THE STENT. THE BROKEN GUIDE CATHETER REMAINED IN THE STENT, HOWEVER, THE PHYSICIAN WAS ABLE TO PULL THE BROKEN GUIDE CATHETER AND STENT INSIDE THE SCOPE BY THE RELEASE IN PRESSURE AND THE DEVICE WAS REMOVED FROM THE PATIENT TOGETHER WITH THE SCOPE. NO FURTHER INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX PRELOADED BILIARY STENT. 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. INVESTIGATION RESULTS REVEALED THE PUSH CATHETER TO BE TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANIX¿ BILIARY BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER M00534330 15430620

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR