BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2003426 · Received March 1, 2011

    Report

    Report Number
    3005099803-2011-00368
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    December 9, 2010
    Report Date
    February 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SUTURE WAS BROKEN AND INSIDE THE STENT BARB. THE SUTURE HOLE ON THE PUSH CATHETER WAS TORN TOWARD THE DISTAL END. THE PUSH CATHETER WAS KINKED NEAR THE PROXIMAL END. THE HUB WAS PULLED OFF THE PUSH CATHETER. THE PROXIMAL END OF THE PUSH CATHETER PRESENTED EVIDENCE OF HEAT STAKING BY THE SUPPLIER BUT THE HUB DID NOT APPEAR TO HAVE BEEN ADEQUATELY MOLDED TO THE EXTRUSION. THE GUIDE CATHETER WAS STRETCHED AND BROKEN INTO 4 PIECES WITH ONLY 3 SECTIONS RETURNED FOR EVALUATION. THE DISTAL SECTION OF THE GUIDE CATHETER WAS STUCK ON THE GUIDEWIRE, STILL INSIDE THE PUSH CATHETER, AND STICKING OUT OF THE PROXIMAL END OF THE PUSH CATHETER. THE PROXIMAL PORTION OF THE GUIDE CATHETER WITH HUB WAS NOT RETURNED FOR EVALUATION. THERE WAS NO DAMAGE TO THE STENT. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST LIKELY ROOT CAUSE IS SUPPLIER MANUFACTURE; HOWEVER OPERATIONAL CONTEXT COULD HAVE CONTRIBUTED TO THE MALFUNCTION. SINCE THE MANUFACTURING OF THIS COMPLAINT DEVICE, A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. 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 AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, RESISTANCE WAS MET AS THE GUIDE CATHETER WAS RETRACTED FOR STENT DEPLOYMENT. THE GUIDE CATHETER HUB DETACHED AND THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT SYSTEM WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN FINE 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 M00539220 12688696

    Patients

    Seq Age Sex Outcome Treatment
    1 PENTAX SCOPE