BEUDAMED
    FDA Adverse Event Other Summary report: N

    EAGLE EYE GOLD

    MDR report key: 1202770 · Received October 13, 2008

    Report

    Report Number
    2939520-2008-00022
    Event Type
    Other
    Date Received
    October 13, 2008
    Date of Event
    July 31, 2008
    Report Date
    October 14, 2008
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K051337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER WAS ANALYZED BY ENGINEERING, REGULATORY AND QUALITY AFFAIRS. CATHETER WAS INTACT IN THAT IT REMAINED IN ONE PIECE WITH NO PORTIONS DETERMINED TO BE MISSING. THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT THE GUIDEWIRE LUMEN WAS DAMAGED. FURTHER INVESTIGATION REVEALED THAT THE GUIDE WIRE PROTRUDED OUTSIDE THE GUIDE LUMEN OF THE CATHETER. THIS WILL PREVENT THE GUIDEWIRE FROM GOING THROUGH THE EXIT PORT SKIVES. RESISTANCE WILL BE FELT WHEN THE GUIDE WIRE REACHES THE TRANSITION BOND AND WILL PREVENT IT FROM ADVANCING. THERE WAS NO PT IMPACT ASSOCIATED WITH THIS INCIDENT, THIS REPORT IS BEING SENT AS A NOTIFICATION.

    Description of Event or Problem · 1

    RESISTANCE FELT WHILE LOADING CATHETER OVER GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE EYE GOLD IVUS CATHETER DQO VOLCANO CORPORATION 85900 002-09714

    Patients

    Seq Age Sex Outcome Treatment
    1