BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 6105677 · Received November 16, 2016

    Report

    Report Number
    2134265-2016-10360
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Report Date
    October 24, 2016
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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: 2134265-2016-10600 AND 2134265-2016-10599. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN OPTICROSS" 6 IMAGING CATHETER AND A PULLBACK SLED TO VIEW THE TARGET LESION. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS DOING A POST STENTING INTRAVASCULAR ULTRASOUND (IVUS) WITH AN OPTICROSS" 6 IMAGING CATHETER, THE PULLBACK SLED FAILED TO PERFORM AUTOMATIC PULLBACK WHEN INITIATED. THE PROCEDURE WAS COMPLETED USING THE MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755955 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1