BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 2191816 · Received July 28, 2011

    Report

    Report Number
    2020394-2011-00173
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K101431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE DELIVERY SYSTEM WAS DISCARDED BY THE USER FACILITY. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEGS OF A IVC FILTER DID NOT COMPLETELY OPEN ONCE THE FILTER WAS DEPLOYED AT THE INTENDED TREATMENT SITE. ANOTHER IVC FILTER WAS THEN IMPLANTED ABOVE THE FIRST IVC FILTER. NO REPORT OF INJURY TO THE PT.

    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