BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER

    MDR report key: 9950703 · Received April 10, 2020

    Report

    Report Number
    2020394-2020-02630
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Report Date
    July 21, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBERS FOR THE 67 MALFUNCTIONS WERE NOT PROVIDED, A LOT HISTORY REVIEW COULD NOT BE PERFORMED. OUT OF THE 67 REPORTED MALFUNCTIONS, NO DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE DUE TO NO SAMPLE RETURN. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENTS IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. RAMAN UBEROI, CHARLES ROSS TAPPING, NICHOLAS CHALMERS, VICTORIA ALLGAR (2013). BRITISH SOCIETY OF INTERVENTIONAL RADIOLOGY (BSIR) INFERIOR VENA CAVA (IVC) FILTER REGISTRY. CARDIOVASC INTERVENT RADIOL, 36:1548¿1561. DOI: 10.1007/S00270-013-0606-2. H10: G3. H11: G1, H6(CONCLUSION). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 67 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL UNKNOWN G2 VENA CAVA FILTER ALLEGEDLY EXPERIENCED PATIENT-DEVICE INCOMPATIBILITY, MIGRATION OR EXPULSION OF DEVICE, AND DIFFICULT TO REMOVE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OUT OF THE 67 REPORTED MALFUNCTIONS, ALL INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBERS FOR THE 67 MALFUNCTIONS WERE NOT PROVIDED, A LOT HISTORY REVIEW COULD NOT BE PERFORMED. OUT OF THE 67 REPORTED MALFUNCTIONS, NO DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE INVESTIGATION IS INCONCLUSIVE DUE TO NO SAMPLE RETURN. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENTS IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 67 MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL UNKNOWN G2 VENA CAVA FILTER ALLEGEDLY EXPERIENCED PATIENT-DEVICE INCOMPATIBILITY, MIGRATION OR EXPULSION OF DEVICE, AND DIFFICULT TO REMOVE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OUT OF THE 67 REPORTED MALFUNCTIONS, ALL INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414357 G2 FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown