BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM, FEMORAL

    MDR report key: 1033486 · Received April 23, 2008

    Report

    Report Number
    2020394-2008-00093
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT THE LOT MET ALL RELEASE CRITERIA. UPON INSPECTION OF THE RETURNED SAMPLE, THE TUOHY NUT WAS TIGHT. VIEWING THE RETURNED SAMPLE UNDER MAGNIFICATION, A HOOK HAD POPPED OUT OF ITS TIGHT SPLINE SLOT AND WAS WEDGED BETWEEN THE OUTER DIAMETER OF THE TIGHT SPLINE AND THE ID OF THE STORAGE TUBE. LOOSENED THE TUOHY NUT AND SLIGHTLY PULLED BACK ON THE PUSHERWIRE AND FILTER AND WAS ABLE TO MANIPULATE THE MISPLACED HOOK TO NEST BACK INTO THE TIGHT SPLINE SLOT. THE FILTER WAS ABLE TO BE REMOVED EASILY FROM THE STORAGE TUBE. THERE WAS AN INDENTATION ON THE OD OF THE TIGHT SPLINE WHERE THE FILTER HOOK HAD BEEN WEDGED BETWEEN THE STORAGE TUBE ID AND THE TIGHT SPLINE OD. THE Y-BODY EXHIBITED NO DEFECTS AND WAS INTACT. THE STORAGE TUBE EXHIBITED EVIDENCE OF STOPPING AND STARTING, AND PUSHING AND PULLING. THERE WERE SCRATCH MARKS AND TWISTING MARKS ON THE ID OF THE STORAGE TUBE. HEAT WAS APPLIED TO THE FILTER AND THE FILTER TOOK SHAPE. ALL ARMS, LEGS AND HOOKS WERE PRESENT AND INTACT. THE PUSHER WIRE HAD APPROXIMATELY 6CM FROM THE PROXIMAL END. OTHERWISE THE PUSHERWIRE WAS CLEAN AND INTACT. ALL MEASUREMENTS TAKEN WERE WITHIN SPECIFICATIONS. THE RESULT OF THE INVESTIGATION WAS CONFIRMED FOR FAILURE TO DEPLOY. BASED ON THE EVALUATION OF THE SAMPLE, THE ROOT CAUSE MAY BE RELATED TO USER HANDLING (RETRACTION DURING DELIVERY), BUT THIS COULD NOT BE CONFIRMED. HANDLING OF G2 FILTER SYSTEM FROM THE IFU. 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, UN-SHEATH THE STATIONARY FILTER BY WITHDRAWING THE INTRODUCER CATHETER. DO NOT TWIST THE PUSHER WIRE HANDLE AT ANY TIME DURING THE PROCEDURE. WARNINGS: 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 THE FILTER LEGS OR ARMS, AND COULD PREVENT THE FILTER FROM FURTHER ADVANCEMENT WITHIN THE INTRODUCER CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENA CAVA FILTER FAILED TO DEPLOY. THE FILTER WAS OUT OF THE SHEATH APPROXIMATELY 1 CM BUT WOULD NOT ADVANCE ANY FURTHER. THE FILTER SYSTEM WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM, FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFRL1996

    Patients

    Seq Age Sex Outcome Treatment
    1