BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM CATHETER VOLCANO 150CM

    MDR report key: 2982726 · Received February 21, 2013

    Report

    Report Number
    MW5029162
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 14, 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

    PHYSICIAN PERFORMING DIAGNOSTIC CARDIAC CATH, ATTEMPTED IVUS INTERROGATION OF LAD, INSERTER EAGLE EYE PLATINUM CATHETER AND THE IVUS MACHINE DID NOT RECOGNIZE THE CATHETER, UNABLE TO OBTAIN DIAGNOSTIC MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75242 EAGLE EYE PLATINUM CATHETER VOLCANO 150CM IVUS CATHETER OBJ VOLCANO CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other