BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 1802539 · Received August 9, 2010

    Report

    Report Number
    2020394-2010-00244
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND IN THE RECORDS TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE FILTER REMAINS IMPLANTED; THEREFORE, IT IS NOT AVAILABLE FOR EVAL. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX TWO WEEKS AFTER FILTER IMPLANT, IT WAS IDENTIFIED THAT THE FILTER WAS TILTED APPROX 45 DEGREES. THE PHYSICIAN DEPLOYED ANOTHER FILTER BELOW THE FIRST ONE. THERE WAS NO REPORT OF INJURY TO THE ASYMPTOMATIC PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFUA4057

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention