BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM

    MDR report key: 1915287 · Received November 17, 2010

    Report

    Report Number
    2020394-2010-00343
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Report Date
    October 29, 2010
    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 PERFORMED. THE SAMPLE WAS DISCARDED BY THE USER FACILITY. THEREFORE, A DEVICE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FILTER LIMB DETACHED. THE FILTER WAS EXAMINED AFTER A SUCCESSFUL SCHEDULED RETRIEVAL AND A FILTER LEG WAS MISSING. IMAGING IDENTIFIED THE FILTER LEG WAS STILL IN THE IVC. THE DETACHED LIMB WAS SUCCESSFULLY RETRIEVED THROUGH THE SAME JUGULAR ACCESS SITE. THE PT IS ASYMPTOMATIC.

    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