BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 2112698 · Received April 29, 2011

    Report

    Report Number
    2020394-2011-00100
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 DETERMINED. THE SAMPLE HAS BEEN RETURNED TO THE MFR FOR EVAL. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON SUCCESSFUL RETRIEVAL OF AN IVC FILTER, IT WAS OBSERVED THAT ONE OF THE FILTER LIMBS WAS DETACHED. THE LOCATION OF THE LIMB COULD NOT BE DETERMINED BY IMAGING. THE PT IS REPORTED TO BE ASYMPTOMATIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR