BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA ICE INTRACARDIAC ECHO CATHETER

    MDR report key: 3972675 · Received July 25, 2014

    Report

    Report Number
    3972675
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ULTRA ICE CATHETER INSERTED INTO THE BODY THEN CONNECTED TO THE MACHINE AND AN ERROR "MDV MALFUNCTION" APPEARED ON SCREEN. DISCONNECTED FROM MACHINE AND CHECKED CATHETER. ERROR RECEIVED SECOND TIME SO A NEW CATHETER WAS USED AND WORKED FINE. PATIENT DID WELL AND WAS NOT AFFECTED BY THE DEFECTIVE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436702 ULTRA ICE INTRACARDIAC ECHO CATHETER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BOSTON SCIENTIFIC 9900 16912731

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR