BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUTRAK 2 PTA BALLOON DILATATION CATHETER

    MDR report key: 2983272 · Received February 1, 2013

    Report

    Report Number
    2020394-2013-00024
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 28, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE SAMPLE HAS NOT BEEN RETURNED TO THE MFR TO DATE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON WAS DIFFICULT TO DEFLATE AFTER USED IN THE SFA. REPORTEDLY, THE BALLOON WAS MANIPULATED UNTIL DEFLATION WAS ACHIEVED. NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45248 VASCUTRAK 2 PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFWB3352

    Patients

    Seq Age Sex Outcome Treatment
    1