BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 6171803 · Received December 13, 2016

    Report

    Report Number
    2134265-2016-11461
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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: 2134265-2016-11459 AND 2134265-2016-11460. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 240V ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN ATLANTIS¿ SR PRO IMAGING CATHETER AND A PULLBACK SLED TO VIEW THE TARGET LESION. DURING THE PROCEDURE, MOTORDRIVE OVERLOAD ERROR MESSAGE OCCURRED. THE PHYSICIAN INITIATED THE AUTOMATIC PULLBACK; HOWEVER, AFTER FEW SECONDS, THE AUTOMATIC PULLBACK STOPPED. THE PHYSICIAN TRIED TO USE MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822981 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1