BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 X FILTER SYSTEM - FEMORAL

    MDR report key: 2944221 · Received January 10, 2013

    Report

    Report Number
    2020394-2013-00008
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Report Date
    December 14, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K082305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 UPON DEPLOYMENT OF A VENA CAVA FILTER, TWO OF THE FILTER LEGS APPEARED TO BE ENTANGLED WITH EACH OTHER. ATTEMPTS TO REMOVE THE FILTER WERE PERFORMED ON TWO SEPARATE OCCASIONS OVER A TEN-MONTH PERIOD; HOWEVER, BOTH ATTEMPTS WERE UNSUCCESSFUL. THE FILTER WILL REMAIN IMPLANTED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15988 G2 X FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1