BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3884640 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03762
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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 2134265-2014-03694 AND 2134265-2014-03761. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING THE PREPARATION OF A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS WAS USED TO A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION LOCATED AT THE MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY WITH 75 PERCENT STENOSIS. THE DEVICE WAS CONNECTED TO THE MDU5 PLUS AND WAS RECOGNIZED BUT IMAGE DID NOT APPEAR AND IT WAS NOT ABLE TO DO PULLBACK. RECONNECTION AND FLUSHING WERE MADE, BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED WITH THE SAME SLED, THE SAME MDU5+ AND A NEW OPTICROSS. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT'S CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361077 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1