BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .038 GLIDEWIRE BOSTON SCIENTIFIC

    MDR report key: 501025 · Received November 21, 2003

    Report

    Report Number
    501025
    Event Type
    Malfunction
    Date Received
    November 21, 2003
    Date of Event
    August 20, 2003
    Report Date
    September 1, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT TO O.R. FOR CYSTOSCOPY, PLACEMENT OF LEFT URETERAL CATHETER AND EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY. AFTER THE SURGEON PLACED THE DOUBLE J STENT, THE ADVANCING DEVICE WOULD NOT SLIDE BACK OVER GLIDEWIRE. AFTER REPEATED ATTEMPTS, THE SURGEON ATTEMPTED TO REMOVE ALL 3 PIECES (GLIDEWIRE, DOUBLE J STENT, ADVANCING DEVICE). THE GLIDEWIRE AND ADVANCING DEVICE WERE REMOVED WITH DOUBLE J STENT REMAINED IN PT. UPON EXITING PT, GLIDEWIRE COVERING APPEARED FRAYED. ADVANCING DEVICE USED TO REMOVE ALL 3 PIECES. AT THE TIME OF REMOVAL APPROX A 3 INCH STRIP OF THE GLIDEWIRE APPEARED TO BE STRIPPED OF COATING, AND SILVER METAL PIECE FROM ADVANCING DEVICE WAS STUCK TO GLIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 .038 GLIDEWIRE BOSTON SCIENTIFIC UROLOGY GLIDEWIRE DQX BOSTON SCIENTIFIC CORPORATION 630-111 030311
    2 COOK/SOF-FLEX AQ MULTI-LENGTH STENT SET 6 FRENCH DOUBLE J STENT DQX COOK UROLOGICAL INC. COOK 6 FRENCH DOUBLE J STENT U1099212

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other