BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI JUGULAR SYSTEM

    MDR report key: 3800264 · Received May 1, 2014

    Report

    Report Number
    2020394-2014-00202
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 8, 2014
    Report Date
    February 28, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VENA CAVA FILTER RETRIEVAL PROCEDURE, THE FILTER WAS RETRIEVE SUCCESSFULLY; HOWEVER, TWO DETACHED LIMBS WERE DISCOVERED. A DETACHED LIMB IN THE IVC WAS CAPTURED AND RETRIEVED SUCCESSFULLY. A SURGERY IS SCHEDULED FOR THE DETACHED LIMB IN THE RIGHT ATRIUM. THE PT IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260974 DENALI JUGULAR SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFXE3419

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other| L| R| H ATENOLOL, METFORMIN AND OMEPRAZOLE| URSODIOL, HYDROCODONE-ACETAMINOPHEN AND DOCUSATE