BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3912036 · Received July 3, 2014

    Report

    Report Number
    2134265-2014-03850
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-03851 AND 2134265-2014-03935. IT WAS REPORTED THAT PULLBACK FAILURE OCCURRED. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH AN OPTICROSS CORONARY CATHETER INTENDED TO VISUALIZE AN UNSPECIFIED LESION. DURING CORONARY INTERVENTION, ERROR MESSAGE WAS DISPLAYED AS WELL AS IT DID NOT PROVIDE AN IMAGE AND FAILURE TO PERFORMED AUTOMATIC PULLBACK. THE PHYSICIAN USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390600 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200 S1003825

    Patients

    Seq Age Sex Outcome Treatment
    1