BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 4200694 · Received October 24, 2014

    Report

    Report Number
    2134265-2014-06490
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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: 2134265-2014-06776, 2134265-2014-06686. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, MILDLY CALCIFIED AND PRE DILATED DISTAL RIGHT CORONARY ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN OPTICROSS¿ IMAGING CATHETER WAS USED IN CONJUNCTION WITH AN ILAB ULTRASOUND IMAGING SYSTEM AND A GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SLED TO PERFORM AUTOMATIC PULLBACK. HOWEVER, IT WAS NOTED THAT THE TRANSDUCER OF THE OPTICROSS¿ IMAGING CATHETER COULD NOT BE MOVED. IT WAS ALSO NOTED THAT THE AUTOMATIC PULLBACK FAILED THUS THE TRANSDUCER COULD NOT BE RETURNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679322 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200 S1004081

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR BALLOON: MAVERICK 2.0X25