BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3884618 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03802
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    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 MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. 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 MDR: 2134265-2014-03639; 2134265-2014-03803. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 240V ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN UNSPECIFIED BSC IMAGING CATHETER IN A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PERFORM PULLBACK BUT AUTOMATIC PULLBACK FAILED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361497 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1