BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 6094212 · Received November 10, 2016

    Report

    Report Number
    2134265-2016-10765
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    October 12, 2016
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2016-10766 AND 2134265-2016-10764. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN IMAGING CATHETER AND A PULLBACK SLED TO VISUALIZE THE UNSPECIFIED TARGET LESION. DURING A PROCEDURE, AN ABNORMAL SOUND WAS HEARD FROM THE MOTOR DRIVE UNIT 5 PLUS, IT DID NOT PULLBACK AND STOPPED SOMETIMES. THE PHYSICIAN RECONNECT THE CATHETER, HOWEVER THE ISSUE WAS NOT RESOLVE. THE ISSUE WAS RESOLVED BY REBOOTING THE SYSTEM AND RECONNECT THE MOTOR DRIVE UNIT 5 PLUS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745396 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1