BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 2945379 · Received December 26, 2012

    Report

    Report Number
    2020394-2012-00292
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    September 17, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    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 UPON DEPLOYMENT OF A VENA CAVA FILTER, THE LEGS WERE CROSSED AND DID NOT EXPAND FULLY. THE FILTER WAS NOT RETRIEVED; HOWEVER, ANOTHER VENA CAVA FILTER WAS SUCCESSFULLY DEPLOYED SUPERIOR TO THE FIRST FILTER. NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFWE3428

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR