BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 4182438 · Received October 17, 2014

    Report

    Report Number
    2134265-2014-06405
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: 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: 2134265-2014-06406, 2134265-2014-06374. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS¿ IMAGING CATHETER WAS USED IN CONJUNCTION WITH ILAB ULTRASOUND IMAGING SYSTEM AND A SLED TO PERFORM AUTOMATIC PULLBACK. HOWEVER, IT WAS NOTED THAT PULLBACK FAILURE OCCURRED. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE AFTER THE OPTICROSS¿ IMAGING CATHETER WAS EXCHANGED TO ANOTHER OPTICROSS¿ IMAGING CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED WHICH WAS LOCATED IN THE MILDLY CALCIFIED AND NON TORTUOUS DISTAL RIGHT CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661865 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1