BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3834251 · Received May 28, 2014

    Report

    Report Number
    2134265-2014-03094
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 MDR ID # 2134265-2014-03093, 2134265-2014-03095 AND 2134265-2014-03096. IT WAS REPORTED THAT MOTOR DRIVE UNIT (MDU) AUTOMATIC PULLBACK FAILURE OCCURRED. DURING PROCEDURE, IT WAS REPORTED THAT THE MOTOR DRIVE UNIT AUTOMATIC PULLBACK WAS NOT OPERATIONAL. NORMAL LCD WAS DISPLAYED. THE SLED WAS CHANGED OUT, BUT ISSUE REMAINED. MANUAL PULLBACK WAS PERFORMED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313158 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1