BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSI

    MDR report key: 2072695 · Received April 25, 2011

    Report

    Report Number
    MW5020402
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT APPEARED TO HAVE SEPARATED FROM HOUSING WHEN REMOVED FROM BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSI DIAMONDBACK CLASSIC 1.5 MCW CARDIOVASCULAR SYSTEMS, INC. DB-150L 32384

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR