BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAICE INTRACARDIAC ECHO CATHETER

    MDR report key: 1182624 · Received September 21, 2008

    Report

    Report Number
    1182624
    Event Type
    Malfunction
    Date Received
    September 21, 2008
    Date of Event
    July 15, 2008
    Report Date
    September 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ONCE THE CATHETER WAS HOOKED UP TO THE ULTRASOUND HANDLE OF THE GALAXY, NO PICTURE WAS PRODUCED. THERE WAS NO WARNING MESSAGE. REPLACED THE CATHETER WITH A NEW ONE AND PROBLEM WAS FIXED. NO HARM OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAICE INTRACARDIAC ECHO CATHETER CATHETER, ULTRASOUND, IMAGING IYO BOSTON SCIENTIFIC CORPORATION NA 11758272

    Patients

    Seq Age Sex Outcome Treatment
    1 *