BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUTRAK PTA BALLOON DILATATION CATHETER

    MDR report key: 3071177 · Received April 8, 2013

    Report

    Report Number
    2020394-2013-00097
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WAS REPORTED VIA FDA USER FACILITY MEDWATCH REPORT 1000060000-2013-8009. THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REPORTED. 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 AFTER INFLATION AND REMOVAL OF A PTA BALLOON, THE DISTAL TIP OF THE CATHETER WAS NOTED TO BE DETACHED FROM THE DEVICE. THERE WAS NO REPORT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143009 VASCUTRAK PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFVK3340

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR