BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE GOLD

    MDR report key: 1813274 · Received August 19, 2010

    Report

    Report Number
    1813274
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 9, 2010
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THREADING THE EAGLE EYE IVUS (INTRAVASCULAR ULTRASOUND) CATHETER OVER THE INTERVENTIONAL WIRE (BMW) AND THE WIRE WOULD NOT THREAD THROUGH THE EXIT PORT. CLEANED WIRE MULTIPLE TIMES - TRIED TO THREAD IVUS CATHETER TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE EYE GOLD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR