BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLCANO

    MDR report key: 4253525 · Received November 10, 2014

    Report

    Report Number
    MW5039070
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 21, 2014
    Manufacturer
    VOLCANO CORP
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DELAY OF CASE BECAUSE VOLCANO EAGLE EYE CATHETER FAILED DURING RECOGNITION TO PIM PHASE. CATHETER BLACKED OUT DURING AN IVUS RUN. CATHETER WAS NOT RECOGNIZED BY PIM. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722472 VOLCANO EAGLE EYE PLATINUM RX DIGITAL IVUS CATHETER OBJ VOLCANO CORP 012750022496076

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR