BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 3883212 · Received February 20, 2014

    Report

    Report Number
    2020394-2014-00050
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT OF A VENA CAVA FILTER, THE LAST TWO LEGS OF THE FILTER REMAINED IN THE DELIVERY SHEATH. THE FILTER DEPLOYMENT WAS COMPLETED WITH ADDITIONAL MANIPULATION OF THE FILTER; HOWEVER, THE TWO FILTER LEGS WERE CROSSED AND THE FILTER BECAME TILTED. THE FILTER WAS RETRIEVED WITH A SNARE DEVICE AND ANOTHER WAS DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107862 DENALI FEMORAL SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. GFXH2808

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention