BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM

    MDR report key: 3172753 · Received June 3, 2013

    Report

    Report Number
    2020394-2013-00174
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENA CAVA FILTER POST DEPLOYMENT OF APPROXIMATELY 3 YEARS, WAS DISCOVERED TO HAVE A DETACHED LIMB. THE FILTER WAS RETRIEVED SUCCESSFULLY; HOWEVER, THE DETACHED LIMB REMAINS EMBEDDED IN THE IVC WALL. PATIENT STATUS IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244833 G2 FILTER SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1