BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY STENT SYSTEM

    MDR report key: 1082524 · Received July 22, 2008

    Report

    Report Number
    3005099803-2008-01223
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK, THEREFORE, THE MFR DATE CANNOT BE DETERMINED. ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN REC'D. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE BACKLOADING THE REPORTED PRODUCT OVER THE WIRE, IT WAS NOTED THAT THE PLASTIC SHEATH OF THE WIRE WAS TORN AND WRINKLED, WHICH PREVENTED PASSAGE OF THE STENT. REPORTEDLY, THE STENT DELIVERY SYSTEM AND THE GUIDEWIRE WERE REMOVED WITH NO PROBLEMS. A SECOND RX BILIARY STENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK