BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM

    MDR report key: 852780 · Received May 15, 2007

    Report

    Report Number
    2020394-2007-00168
    Event Type
    Malfunction
    Date Received
    May 15, 2007
    Date of Event
    March 14, 2007
    Report Date
    April 16, 2007
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE CATALOG NUMBER IS UNKNOWN AND IT WAS REPORTED ONLY AS A G2 FILTER, THEREFORE, THE 510(K) NUMBER IS REPORTED AS K052578. THE RESULT OF THE INVESTIGATION WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. IT IS UNKNOWN IF PT OR PROCEDURAL FACTORS CONTRIBUTED TO THIS EVENT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN. THE CURRENT IFU (INFORMATION FOR USE) FOR THIS DEVICE STATES: THE G2 FILTER IS DESIGNED TO ACT AS A PERMANENT FILTER. THE SAFETY AND EFFECTIVENESS OF THE G2 FILTER SYSTEM AS A RETRIEVABLE OR TEMPORARY FILTER HAVE NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DOCTOR TRIED TO RETRIEVE THE DEVICE 3 MONTHS AFTER IT WAS IMPLANTED, BUT WAS UNSUCCESSFUL. A CT AND CAVAGRAM REVEALED THAT THE APEX WAS TILTED INTO THE CAVAL WALL AND NOT ALL OF THE LEGS WERE TOUCHING THE WALL OF THE CAVA. NO INJURY TO THE PT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR