BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACCESS PTA BALLOON DILATATION CATHETER

    MDR report key: 3071191 · Received April 8, 2013

    Report

    Report Number
    2020394-2013-00100
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K1111850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE DEVICE HAS NOT BEEN RETURNED FOR EVAL TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON RUPTURED AND THE TIP OF THE BALLOON DETACHED. THE DETACHED TIP WAS SUCCESSFULLY REMOVED USING A SNARE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144530 VACCESS PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 93AX0212

    Patients

    Seq Age Sex Outcome Treatment
    1