BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS .035" OTW PTA DILATATION CATHETER (7MM)

    MDR report key: 1960974 · Received January 11, 2011

    Report

    Report Number
    MW5018962
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 6, 2011
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING BALLOON ANGIOPLASTY IN RIGHT UPPER EXTREMITY FISTULA. A 7 MM. BALLOON WAS ADVANCED ACROSS THE VENOUS ANASTOMOSIS AND DILATATION WAS DONE. AT APPROX MAXIMUM BALLOON PRESSURE TOLERANCE, THE BALLOON RUPTURED. WHEN THE BALLOON WAS DEFLATED, APPROX 50% OF THE BALLOON WAS NOT ON THE CATHETER. FLUOROSCOPICALLY THE PIECE OF THE BALLOON FRAGMENT COULD BE SEEN AT THE JUNCTION OF THE STENOSIS AND IN THE AXILLARY VEIN. IT APPEARED THAT THE GUIDE WIRE WAS WITHIN THE BALLOON FRAGMENT. A 9 FRENCH SHEATH WAS PLACED INTO THE ANTEGRADE SIDE OF THE FISTULA AND AN ADDITIONAL GUIDE WIRE PLACED. OVER THE GUIDE WIRE, A GOOSENECK SNARE WAS MANIPULATED INTO THE SUBCLAVIAN VEIN WHERE THE PREVIOUSLY PLACED GUIDE WIRE...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERCROSS .035" OTW PTA DILATATION CATHETER (7MM) PTA DILATATION CATHETER DQY EV3 INC. AB35W07040080 8474296

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention