BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3122273 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03431
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE PRODUCT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE EXTERNAL DAMAGE OR DEFECTS OBSERVED. THE MDU WAS FUNCTIONALLY TESTED AND MET SPECIFICATIONS. IN ADDITION TO THE FUNCTIONAL TEST, THE UNIT UNDERWENT A 4 HOUR BURN-IN WITHOUT ANY FAILURES OBSERVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED . (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03435, 2134265-2013-03434. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, PULLBACK FAILURE OCCURED. WHILE USING THE ILAB ULTRASOUND IMAGING SYSTEM, THE MDU STOPPED ROTATING AND THE PHYSICIAN WAS UNABLE TO PERFORM AUTOMATIC PULLBACK. IT WAS NOT KNOWN IF MANUAL PULLBACK WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT IVUS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224191 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (CE) H749I5129H0 0000003151

    Patients

    Seq Age Sex Outcome Treatment
    1