BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1792091 · Received August 10, 2010

    Report

    Report Number
    3005099803-2010-03430
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    May 31, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY OVER 18 YEARS. A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THE PUSH CATHETER WAS KINKED NEAR THE LUER AT THE PROXIMAL END. THE PUSH CATHETER WAS BROKEN CLOSE TO THE RO MARKER LOCATION AT THE DISTAL END. THE GUIDE CATHETER ASSEMBLY WAS BROKEN NEAR THE DISTAL END WITH THE DISTAL PIECE REMAINING INSIDE THE STENT. THE PROXIMAL PIECE OF GUIDE CATHETER WAS STRETCHED AND BROKEN. THE REMAINDER OF THE GUIDE CATHETER REMAINED INSIDE THE DELIVERY SYSTEM AND COULD NOT BE REMOVED. THE DISTAL END OF THE GUIDE CATHETER CONTAINED A KINK/BEND (SUTURE IMPRESSION). THE STENT, INTACT VIA THE SUTURE, WAS LOADED ON THE BROKEN DISTAL GUIDE CATHETER PIECE AND WAS DEFORMED AND KINKED/BENT NEAR THE PROXIMAL BARB. THE SUTURE WAS TWISTED/TENSED AROUND THE PROXIMAL BARB OF THE STENT. THE TOUHY BORST WAS NOT RETURNED FOR ANALYSIS. UPON EXAMINING THE DEVICE, THE STENT WAS DETACHED FROM THE PUSH CATHETER BY CUTTING THE SUTURE AND THE DISTAL BROKEN PIECE OF GUIDE CATHETER WAS REMOVED. THE BROKEN PUSH CATHETER WAS DUE TO THE CUSTOMER CUTTING THE DEVICE. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM WAS USED DURING A DRAINAGE AND BILE DUCT STONE REMOVAL PROCEDURE IN THE BILE DUCT OF A MALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, RESISTANCE WAS MET AS THE GUIDE CATHETER WAS WITHDRAWN FOR STENT DEPLOYMENT. THE GUIDE CATHETER BECAME STRETCHED, AND THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE AND NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER THE PROCEDURE. AFTER THE PROCEDURE, THE PHYSICIAN CUT THE TIP OF THE DEVICE TO INVESTIGATE HOW THE DEVICE FAILED. THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF FAILURE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; DEFORMED STENT DEFORMED AND BROKEN GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00539200 13387717

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE:RUNGLER 0.035INCH(PIOLAX)| SCOPE:JF-240 WORKING CHANNEL IS 3.2MM (OLYMPUS)