BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 3973232 · Received June 6, 2014

    Report

    Report Number
    2020394-2014-00251
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPT TO PLACE THE VENA CAVA FILTER DELIVERY SYSTEM, THE MARKER BAND DETACHED. THE DETACHED MARKER WAS LOCATED NEAR THE ACCESS SITE UNDER THE SKIN. THE MARKER WAS REMOVED AND A NEW FILTER WAS SUCCESSFULLY DEPLOYED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331537 G2 FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFVF2212

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR