BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2X FILTER SYSTEM - FEMORAL

    MDR report key: 1881560 · Received October 20, 2010

    Report

    Report Number
    2020394-2010-00311
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K082305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 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 DEVICE REMAINS IMPLANTED WITHIN THE PATIENT. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED RETRIEVAL OF AN IVC FILTER, ANGIOGRAPHY DEMONSTRATED THAT THE FILTER HAD MIGRATED CAUDALLY AND A FEW FILTER LIMBS APPEARED TO BE PERFORATING THE WALL OF THE VENA CAVA. HOWEVER, NO EXTRAVASATION WAS NOTED. THE PHYSICIAN DECIDED NOT TO RETRIEVE THE FILTER AT THIS TIME. REPORTEDLY, THE PATIENT HAD ABDOMEN PAIN THREE DAYS POST IMPLANT, HOWEVER, THERE WAS NO TREATMENT PERFORMED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2X FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFTL2137

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR