BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM, FEMORAL

    MDR report key: 1120612 · Received August 13, 2008

    Report

    Report Number
    2020394-2008-00222
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Report Date
    July 17, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 VENA CAVA FILTER DELIVERY SYSTEM WAS RETURNED, BUT THE SHEATH AND THE DILATOR WERE NOT INCLUDED. THE TOUHY WAS TIGHT. THERE WERE SEVERAL ATTEMPTS TO FLUSH THE STORAGE TUBE WITH MINIMAL SUCCESS. AFTER THE SOAKING PROCESS, THE STORAGE TUBE WITH THE FILTER INSIDE WAS OBSERVED UNDER THE MICROSCOPE. IT WAS FOUND THAT ONE HOOK WAS DISLODGED FROM THE GROOVE, AND IT HAD CROSSED OVER THE HOOK NEXT TO IT IN THE TIGHT SPLINE. CIRCUMERENTIAL SCRATCHES WERE ALSO NOTICED ON THE INSIDE OF THE STORAGE TUBE. THE FILTER WAS PUSHED OUT OF THE STORAGE TUBE BY TWISTING THE FILTER WITH THE PUSHER WIRE AND PUSHING FORWARD. THE STORAGE TUBE WAS VISIBLE BENT. THE STORAGE TUBE ID WAS MEASURED AND WITHIN SPECIFICATIONS. HEAT WAS APPLIED TO THE FILTER AND THE FILTER TOOK SHAPE. ALL ARMS AND LEGS/HOOKS WERE PRESENT AND INTACT. ALL MEASUREMENTS TAKEN WERE WITHIN SPECIFICATIONS. THIS INVESTIGATION IS CONFIRMED FOR FAILURE TO DEPLOY. THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE CURRENT INSTRUCTIONS FOR USE (IFU) STATES: DO NOT DELIVERY THE FILTER BY PUSHING IT BEYOND THE END OF THE INTRODUCER CATHETER. TO ACHIEVE PROPER PLACEMENT, UNSHEATHE THE STATIONARY FILTER BY WITHDRAWING THE INTRODUCER CATHETER. DO NOT TWIST THE PUSHER WIRE HANDLE AT ANY TIME DURING THIS PROCEDURE. WARNINGS: THE CURRENT INFO FOR USE (IFU) STATES: DELIVERY OF THE G2 FILTER THROUGH THE INTRODUCER CATHETER IS ADVANCE ONLY. RETRACTION OF THE PUSHER WIRE DURING DELIVERY COULD RESULT IN DISLODGEMENT OF THE FILTER, CROSSING OF 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 AN IVC FILTER WOULD NOT DEPLOY. THE PHYSICIAN STATED THAT IT LOOKED AS IF THE FILTER WAS "TWISTED" EVEN BEFORE IT WENT INTO THE SHEATH. HE REMOVED THE FEMORAL FILTER, AND USED ANOTHER FOR A SUCCESSFUL PROCEDURE WITHOUT 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. GFSD2852

    Patients

    Seq Age Sex Outcome Treatment
    1