BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUTRAK PTA BALLOON DILATATION CATHETER

    MDR report key: 2843722 · Received October 26, 2012

    Report

    Report Number
    2020394-2012-00240
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 9, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE SAMPLE IS NOT AVAILABLE FOR RETURN; THEREFORE, THE EVAL OF THE DEVICE COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON WAS SLOW TO DEFLATE IN THE SFA. THE ORIGINAL CONTRAST/SALINE RATIO WAS 50/50. EXTRA FLUID WAS APPLIED TO DILUTE THE CONTRAST AND THE BALLOON SUCCESSFULLY DEFLATED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUTRAK PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFVI0545

    Patients

    Seq Age Sex Outcome Treatment
    1