BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 2083091 · Received April 12, 2011

    Report

    Report Number
    2020394-2011-00080
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 18, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    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 FILTER REMAINS IMPLANTED. THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IVC FILTER DID NOT OPEN PROPERLY ONCE DEPLOYED IN THE PATIENT. REPORTEDLY, THE LEGS WERE MANIPULATED AFTER THE DEVICE WAS DEPLOYED AND THE FILTER SUCCESSFULLY OPENED. NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFUE4488

    Patients

    Seq Age Sex Outcome Treatment
    1