BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM - JUGULAR

    MDR report key: 3761163 · Received December 31, 2013

    Report

    Report Number
    2020394-2013-00482
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    July 13, 2011
    Report Date
    May 31, 2018
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME TIME AFTER IMPLANTATION OF A VENA CAVA FILTER, FILTER TILT WAS DISCOVERED. THE FILTER REMAINS IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682643 ECLIPSE FILTER SYSTEM - JUGULAR VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. GFUH3422

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other WARFARIN, MELOXICAM