BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

    MDR report key: 1160906 · Received June 6, 2008

    Report

    Report Number
    2134265-2008-01595
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K021630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT#: 2134265-2008-01597. IT WAS REPORTED THAT DURING A LEFT SUBCLAVIAN ARTERY STENOSIS PROCEDURE, THE STENT DELIVERY SYSTEM FROZE ON THE GUIDE WIRE. THE 70% TO 80% STENOTIC, DE NOVO LESION WAS LOCATED IN THE SLIGHTLY ANGULATED LEFT SUBCLAVIAN ARTERY. THE MAGIC TORQUE GUIDE WIRE WAS PLACED AND THE LESION WAS PRE-DILATED WITH AN ULTRA THIN SDS BALLOON DILATATION CATHETER OF AN UNK SIZE. THE EXPRESS-BILIARY LD PREMOUNTED 9.0MM X 30MM X 135 CM STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND DEPLOYED SUCCESSFULLY. UPON ATTEMPTING TO WITHDRAW THE STENT DELIVERY SYSTEM, SIGNIFICANT RESISTANCE WAS ENCOUNTERED AND THE CATHETER WAS FROZEN ON THE GUIDE WIRE. THE STENT DELIVERY SYSTEM AND THE GUIDE WIRE WERE WITHDRAWN AS A UNIT. THE STENT WAS POST-DILATED WITH AN ULTRA THIN SDS BALLOON DILATATION CATHETER OF AN UNK SIZE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PT'S STATUS WAS REPORTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 11558335

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR