BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2X FILTER SYSTEM

    MDR report key: 1952283 · Received November 16, 2010

    Report

    Report Number
    2020394-2010-00335
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K082305
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNK. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE COMPLAINT SAMPLE WILL BE RETAINED BY THE USER FACILITY RISK MANAGEMENT DEPARTMENT. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY. RECEIVED A COPY OF USER FACILITY MEDWATCH # UF0501120000-2010-8017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED WITH CHEST PAIN. REPORTEDLY, CT SCANS DEMONSTRATED THAT A FILTER LIMB DETACHED FROM THE FILTER AND MIGRATED TO THE RIGHT VENTRICLE. THE FILTER AND DETACHED LIMB WERE SUCCESSFULLY RETRIEVED WITHOUT INCIDENT. ANOTHER MFR'S IVC FILTER WAS THEN IMPLANTED. AS A PARTIALLY OCCLUSIVE THROMBUS WAS NOTED AT THE CONFLUENCE OF THE IVC. THE PT IS CURRENTLY RECOVERING IN THE ICU.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening