BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM

    MDR report key: 2061844 · Received March 18, 2011

    Report

    Report Number
    2020394-2011-00052
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNK. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE FILTER REMAINS IMPLANTED IN THE PT. THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX THREE MONTHS POST FILTER IMPLANT, A CT SCAN INCIDENTALLY DEMONSTRATED ONE DETACHED FILTER LIMB IN THE KIDNEY. IN ADDITION, IT WAS IDENTIFIED THAT ONE OR TWO LIMBS HAD PENETRATED THE DUODENUM AND SEVERAL FILTER LEGS WERE OUTSIDE THE CONTRAST COLUMN OF THE IVC. AN ATTEMPT TO RETRIEVE THE FILTER USING A SNARE AND A RECOVERY CONE PROVED UNSUCCESSFUL. THE FILTER REMAINS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR