BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 3761171 · Received December 31, 2013

    Report

    Report Number
    2020394-2013-00473
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    September 21, 2009
    Report Date
    December 3, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME TIME AFTER IMPLANTATION OF A VENA CAVA FILTER, IVC PERFORATION WAS DISCOVERED. THE FILTER REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682614 G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFRG2583

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR LOVENOX, COUMADIN| LOVENOX, COUMADIN