BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECOVERY G2 FILTER SYSTEM - FEMORAL

    MDR report key: 1610232 · Received February 5, 2010

    Report

    Report Number
    2020394-2010-00044
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Report Date
    January 8, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS MFG LOT NUMBER. THE FILTER REMAINS IMPLANTED; THEREFORE, NOT AVAILABLE FOR EVAL. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES 510(K) - K062887. IT WAS REPORTED THAT THE DIAMETER OF THE VENA CAVA WAS NOT MEASURED PRIOR TO FILTER IMPLANT. IN ADDITION, IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO RELEASE THE FILTER 1 MM BELOW THE RENAL VEIN. THE INSTRUCTIONS FOR USE (IFU) FOR THIS DEVICE STATES: DO NOT DEPLOY THE FILTER UNLESS THE VENA CAVA HAS BEEN PROPERLY MEASURED. IN ADDITION, IT APPEARS THAT THE FILTER MAY HAVE BEEN MISPLACED PRIOR TO FILTER DEPLOYMENT, AS THE PHYSICIAN ATTEMPTED TO PLACE THE FILTER 1MM BELOW THE RENAL VEIN. THE IFU STATES: POSITION THE FILTER TIP 1 CM BELOW THE LOWEST RENAL VEIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE FINAL RELEASE OF THE FILTER, THE DELIVERY SYSTEM "BLOCKED." THE PHYSICIAN APPLIED FORCE AND WAS ABLE TO RELEASE THE FILTER, BUT THE FILTER JUMPED AHEAD ABOUT 4-5 MM AND WAS POSITIONED ABOVE THE RENAL VEINS. ONE OR TWO FILTER LEGS WENT INTO ONE OF THE RENAL VEINS. NO ACTION WAS TAKEN TO MODIFY THE POSITON OF THE FILTER DUE TO THE PT'S CONDITION. PT'S STATUS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECOVERY G2 FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFTF3370

    Patients

    Seq Age Sex Outcome Treatment
    1