BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM, FEMORAL

    MDR report key: 1013262 · Received March 14, 2008

    Report

    Report Number
    2020394-2008-00047
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THE SAMPLE HAS NOT BEEN RETURNED FOR EVAL AS IT REMAINS IMPLANTED. IT IS UNK IF PT OR PROCEDURAL FACTORS CONTRIBUTED TO THIS EVENT. BASED ON THE INFO RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES THE FOLLOWING: DO NOT DELIVER THE FILTER BY PUSHING IT BEYOND THE END OF THE INTRODUCER CATHETER. TO ACHIEVE PROPER PLACEMENT, UNSHEATH THE STATIONARY FILTER BY WITHDRAWING THE INTRODUCER CATHETER. DO NOT TWIST THE PUSHER WIRE HANDLE AT ANY TIME DURING THE PROCEDURE. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES THE FOLLOWING: DELIVERY OF THE G2 FILTER THROUGH THE INTRODUCER CATHETER IS ADVANCE ONLY. RETRACTION OF THE PUSHER WIRE DURING DELIVERY COULD RESULT IN DISLODGMENT OF THE FILTER, CROSSING OF FILTER LEGS OR ARMS, AND COULD PREVENT THE FILTER FROM FURTHER ADVANCEMENT WITH THE INTRODUCER CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE VENA CAVA FILTER WAS DEPLOYED INFRARENAL, IT WAS NOTED THAT 2 OF THE 6 LEGS WERE CROSSED. THE VENA CAVA FILTER WAS IMPLANTED FOR DVT. THE DOCTOR DID NOT HAVE ANY DIFFICULTY DEPLOYING THE FILTER. THE FILTER REMAINS IN THE PT AND A FOLLOW-UP CT SCAN SHOWED THAT THE FILTER HAD NOT MOVED. THERE ARE NO PLANS TO REMOVE THE FILTER. NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM, FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFRJ2940

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR