BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUTRAK 2 PTA BALLOON DILATATION CATHETER

    MDR report key: 2944295 · Received January 11, 2013

    Report

    Report Number
    2020394-2013-00010
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 EVALUATION TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE FIRST INFLATION THE PTA BALLOON WAS DIFFICULT TO DEFLATE. NO INTERVENTION WAS PERFORMED TO DEFLATE THE BALLOON; REPORTEDLY, THE BALLOON FULLY DEFLATED AFTER 13 MINUTES. UPON DEFLATION, THE BALLOON WAS RETRACTED WITHOUT INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19330 VASCUTRAK 2 PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFWE2808

    Patients

    Seq Age Sex Outcome Treatment
    1