BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSNARE SYSTEM

    MDR report key: 615046 · Received July 30, 2004

    Report

    Report Number
    1036710-2004-00004
    Event Type
    Malfunction
    Date Received
    July 30, 2004
    Date of Event
    July 1, 2004
    Report Date
    July 26, 2004
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    MMX
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PLATINUM RING CAME OFF OF THE INTRODUCER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSNARE SYSTEM VASCULAR RETRIEVAL DEVICE MMX MEDICAL DEVICE TECHNOLOGIES, INC. * 21650DVW

    Patients

    Seq Age Sex Outcome Treatment
    1 *