BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLCANO

    MDR report key: 3866788 · Received June 4, 2014

    Report

    Report Number
    MW5036517
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 3, 2014
    Manufacturer
    VOLCANO CORP
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VOLCANO CATHETER INSERTED TO VERIFY IVC FILTER PLACEMENT. VOLCANO A5 INTRAVASCULAR ULTRASOUND IMAGING SYSTEM MACHINE DISPLAYED MESSAGE "CATHETER NOT PRESENT". THE PRACTITIONER REMOVED THE CATHETER AND INSERTED A SECOND CATHETER, AFTER WHICH THE IMAGING SYSTEM MACHINE DISPLAYED MESSAGE THAT CONFIRMED APPROPRIATE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327194 VOLCANO VOLCANO VISIONS P.V. .035 CATHETER OBJ VOLCANO CORP 88901

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR