BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAVERSE PTA BALLOON DILATATION CATHETER

    MDR report key: 1905807 · Received November 18, 2010

    Report

    Report Number
    2020394-2010-00345
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K93965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED, AND IT WAS CONFIRMED THAT THE LOT MET ALL RELEASE CRITERIA. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TREATMENT IN THE SUPERFICIAL FEMORAL ARTERY, THE PTA BALLOON DETACHED FROM THE CATHETER AS IT WAS BEING RETRACTED INTO THE SHEATH. A STENT WAS IMPLANTED TO SECURE THE BALLOON AGAINST THE WALL OF THE POPLITEAL ARTERY. THE PATIENT WAS REPORTED TO BE DOING FINE POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAVERSE PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. HUUD1899

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention