BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1915176 · Received December 6, 2010

    Report

    Report Number
    3005099803-2010-04937
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 15, 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 THAT THE GUIDE CATHETER WAS STRETCHED AND BROKEN CLOSE TO THE PROXIMAL END. THE STRETCHED AND BROKEN PROXIMAL PIECE OF THE GUIDE CATHETER WAS STUCK ON GUIDEWIRE. THE GUIDEWIRE COULD NOT BE REMOVED FROM THE GUIDE CATHETER DUE TO RESISTANCE. THERE WAS DAMAGE ON THE GUIDEWIRE AND IT WAS NOT A LIKELY CONTRIBUTING FACTOR TOWARDS THE COMPLAINT EVENT. THE DISTAL END OF THE GUIDE CATHETER HAD KINKS/BENDS (SUTURE IMPRESSIONS). THE SUTURE HOLE AT THE DISTAL END OF THE PUSH CATHETER WAS TORN. THERE WAS NO OTHER DAMAGE ON THE PUSH CATHETER. THE TOUHY BORST CAP, STENT, AND SUTURE WERE NOT RETURNED FOR EVALUATION. 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 PROCEDURE IN THE BILE DUCT OF A FEMALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, THE GUIDE CATHETER WAS RETRACTED FOR STENT DEPLOYMENT; HOWEVER THE GUIDE CATHETER BECAME STRETCHED, AND THE STENT WAS UNABLE TO BE DEPLOYED.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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; 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 M00539270 13657578

    Patients

    Seq Age Sex Outcome Treatment
    1