BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 1923339 · Received December 7, 2010

    Report

    Report Number
    2020394-2010-00352
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED. 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. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE FILTER IS NOT AVAILABLE FOR RETURN. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY. DESPITE NUMEROUS ATTEMPTS TO OBTAIN INFORMATION, NO FURTHER INFORMATION HAS BEEN OBTAINED TO DATE. REFERENCE ATTACHED USER FACILITY VOLUNTARY MEDWATCH REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA USER FACILITY VOLUNTARY MEDWATCH REPORT THAT "THE PATIENT HAD AN INFERIOR VENA CAVA (IVC) FILTER PLACED TWO YEARS AGO. THIS MONTH, THE PATIENT UNDERWENT AN IVC GRAM AND INFRARENAL IVC FILTER REMOVAL AS THE DEVICE WAS NO LONGER NEEDED. PRIOR TO ITS REMOVAL, THE FILTER HAD FRACTURED BUT MOST OF THE FILTER WAS ABLE TO BE REMOVED AS PLANNED. HOWEVER, THERE IS A RETAINED LIMB OF THE IVC FILTER WITH ITS DISTAL END EMBEDDED IN A BONY SPUR. THIS IS ARISING FROM THE ANTERIOR ASPECT OF THE LUMBAR FOUR (L4) VERTEBRAL BODY. IT APPEARS THAT A LIMB OF THE DEVICE FRACTURED AT SOME POINT AFTER IT WAS INITIALLY PLACED TWO YEARS AGO, LODGING IN A BONY SPUR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFSH3638

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR