BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVERCROSS PTA BALLOON CATHETER -6MM X 200MM, L =

    MDR report key: 1902911 · Received November 12, 2010

    Report

    Report Number
    MW5018217
    Event Type
    Other
    Date Received
    November 12, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 12, 2010
    Manufacturer
    EV3 ENDOVASCULAR INC.
    Product Code
    DQY
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN INSERTED BALLOON CATHETER INSIDE EXISTING STENT ON PATIENT. BALLOON WAS INFLATED TO EXPAND THE STENT. PHYSICIAN DEFLATED BALLOON AND ATTEMPTED TO REMOVE THE BALLOON CATHETER. DURING THE REMOVAL PROCESS, THE TIP OF THE BALLOON GOT CAUGHT ON THE STENT STRUTS AND THE TIP BROKE OFF. AFTER NUMEROUS UNSUCCESSFUL ATTEMPTS TO SNARE THE BROKEN TIP, THE PHYSICIAN DECIDED TO DEPLOY A SECOND STENT TO COVER THE BROKEN TIP AND OPEN UP THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERCROSS PTA BALLOON CATHETER -6MM X 200MM, L = BALLOON CATHETER DQY EV3 ENDOVASCULAR INC. 8424083

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other