BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3955237 · Received July 24, 2014

    Report

    Report Number
    2134265-2014-04388
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, PRODUCT INSPECTION COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-04390, 2134265-2014-04491 AND 2134265-2014-04490. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH A BSC CORONARY CATHETER INTENDED TO VISUALIZE THE UNSPECIFIED LESION. DURING PREPARATION, THE CUSTOMER WAS ABLE TO SEE IMAGE OF THE INTENDED LESION THROUGH INTRAVASCULAR ULTRASOUND. HOWEVER, AUTOMATIC PULLBACK ATTEMPTED BUT FAILED TO START. THE PROCEDURE WAS COMPLETED USING MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434508 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1