BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1812363 · Received August 24, 2010

    Report

    Report Number
    3005099803-2010-03481
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    June 4, 2010
    Report Date
    August 3, 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

    (B)(4): ALTHOUGH THE LOT NUMBER IS UNKNOWN, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. (B)(4):A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THE WORKING LENGTH OF PUSH CATHETER WAS KINKED AT MULTIPLE PLACES. THE GUIDE CATHETER WAS BROKEN INTO THREE PIECES. THE PROXIMAL END OF THE GUIDE CATHETER WAS STRETCHED. THE DISTAL END OF THE GUIDE CATHETER CONTAINED MULTIPLE KINKS/BENDS. THE SUTURE AND STENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM WAS USED DURING A ERBD (ENDOSCOPIC RETROGRADE BILIARY DRAINAGE)PROCEDURE IN THE MID TO INFERIOR BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, RESISTANCE WAS FELT AS THE GUIDE CATHETER WAS RETRACTED FOR STENT DEPLOYMENT. THE PHYSICIAN WAS ABLE TO RELEASE THE STENT AT THE TARGET SITE AFTER MANIPULATING THE GUIDE CATHETER. THERE WERE NO COMPLICATIONS AND 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 M00539260

    Patients

    Seq Age Sex Outcome Treatment
    1 VISI GRIDE WIRE