BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM IVUX CATHETER

    MDR report key: 2982695 · Received February 21, 2013

    Report

    Report Number
    MW5029150
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 21, 2013
    Manufacturer
    VOLCANO CORP
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC CATHETERIZATION REQUIRED USE OF IVUS CATHETER FOR DIAGNOSIS OF VESSEL CHARACTERISTICS. IVUS CATHETER WAS INTRODUCED, BUT NOT RECOGNIZED. REMOVED WITHOUT INJURY AND REPLACED WITH FUNCTIONING CATHETER. REASON FOR USE: DIAGNOSTIC CARDIAC CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75836 EAGLE EYE PLATINUM IVUX CATHETER IVUS CATHETER OBJ VOLCANO CORP 5F

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other