BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FILTER

    MDR report key: 9604550 · Received January 17, 2020

    Report

    Report Number
    2020394-2020-00639
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Report Date
    July 22, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    UDI-DI
    00801741040795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR ALL FIVE MALFUNCTIONS WERE PROVIDED AND A LOT HISTORY REVIEW WAS PERFORMED. THE DEVICES FOR ALL FIVE MALFUNCTIONS HAS NOT BEEN RETURNED FOR EVALUATION, HOWEVER, MEDICAL RECORDS FOR FOUR MALFUNCTIONS WERE PROVIDED. FOR ONE MALFUNCTION, THE INVESTIGATION IS CONFIRMED FOR MALPOSITION OF DEVICE. FOR ONE MALFUNCTION, THE INVESTIGATION IS UNCONFIRMED FOR MALPOSITION OF DEVICE. FOR THE REMAINING MALFUNCTIONS, THE INVESTIGATION IS INCONCLUSIVE FOR MALPOSITION OF DEVICE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICES ARE LABELED FOR SINGLE USE. H10: D4 (LOT NUMBER: GFXH2811, GFBY2984), G3. 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 FIVE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DL900J VENA CAVA FILTER ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL FIVE MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THE TWO PATIENTS RANGED FROM 74-77 YEARS OF AGE, TWO PATIENTS WEIGHT RANGED FROM 200-234 LBS; TWO PATIENTS WERE REPORTED AS MALE AND ONE PATIENT WAS REPORTED AS FEMALE. ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES FIVE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL DL900J VENA CAVA FILTER ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. ALL FIVE MALFUNCTIONS INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. THE TWO PATIENTS RANGED FROM (B)(6) YEARS OF AGE, ONE PATIENT WEIGHT IS (B)(6) LBS; ONE IS MALE AND ONE IS FEMALE. AGE, GENDER AND WEIGHT OF REMAINING PATIENTS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63862 DENALI FILTER VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. DL900J GFXG3747, GFXK0027, GFXI2529 00801741040795

    Patients

    Seq Age Sex Outcome Treatment
    1