BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI FEMORAL SYSTEM

    MDR report key: 3812451 · Received April 18, 2014

    Report

    Report Number
    2020394-2014-00171
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 25, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE DEPLOYMENT OF A VENA CAVA FILTER, THE FILTER LEGS REMAINED INSIDE THE INTRODUCER SHEATH. THE FILTER DEPLOYMENT WAS COMPLETED WITH ADDITIONAL MANIPULATION OF THE FILTER; HOWEVER, THE FILTER TILTED WITH THE LEGS CROSSED. ADDITIONAL MANIPULATION WAS USED TO STRAIGHTEN THE FILTER AND UNCROSS THE FILTER LEGS. THERE IS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238699 DENALI FEMORAL SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BARD PERIPHERAL VASCULAR, INC. GFXK0065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown