BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2X FILTER

    MDR report key: 11224006 · Received January 25, 2021

    Report

    Report Number
    2020394-2021-80116
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Report Date
    January 25, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OF THE FOUR DEVICES, THREE LOT NUMBERS WERE PROVIDED AND LOT HISTORY REVIEWS WERE PERFORMED. ALL THE FOUR DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, MEDICAL RECORDS WERE PROVIDED FOR ALL MALFUNCTIONS. FOR ALL FOUR MALFUNCTIONS, THE INVESTIGATIONS ARE CONFIRMED FOR PERFORATION OF THE INFERIOR VENA CAVA. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. (CORPORATE LOT NO: UNKNOWN).

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES FOUR MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL RF400F VENA CAVA FILTER ALLEGEDLY EXPERIENCED PATIENT DEVICE INTERACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THIS MALFUNCTION INVOLVED ALL FOUR PATIENTS WITH NO CONSEQUENCES. OF THE FOUR PATIENTS, FOUR PATIENTS' AGES WERE REPORTED TO BE BETWEEN 27-66 YEARS AND TWO PATIENTS¿ WEIGHT WERE REPORTED TO BE BETWEEN 142-420 LBS, TWO PATIENTS WERE REPORTED AS MALE, AND TWO PATIENTS WERE REPORTED AS FEMALE. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119590 G2X FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFUA2474,GFTH3222,GFTJ1664

    Patients

    Seq Age Sex Outcome Treatment
    1