BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 2072583 · Received April 22, 2011

    Report

    Report Number
    2020394-2011-00093
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE RETRIEVED FILTER HAS BEEN RETURNED AND THE EVALUATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST FILTER IMPLANT, DURING A SCHEDULED RETRIEVAL, IT WAS OBSERVED THAT ONE OF THE FILTER LIMBS HAD DETACHED FROM THE REST OF THE IVC FILTER, AFTER THE FILTER HAD SUCCESSFULLY BEEN REMOVED FROM THE PATIENT. REPORTEDLY, THE DETACHED LIMB REMAINED IN THE POSTERIOR WALL OF THE IVC AT THE IMPLANT SITE, WITH NO EXPOSED PORTION AVAILABLE TO ATTEMPT RETRIEVAL. THE PATIENT IS REPORTED TO BE ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFRA1143

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR