BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 2920186 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00150
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BEEN RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-00143, 2134265-2013-00149. IT WAS REPORTED THAT DURING THE USE OF AN INTRAVASCULAR ULTRASOUND DIAGNOSIS DEVICE, THE ILAB ULTRASOUND IMAGING SYSTEM MOTORDRIVE WAS UNABLE TO START THE AUTOMATIC PULLBACK FUNCTION WITH THREE TO FIVE ATTEMPTS. THE SITE CONFIRMED THE SLED AND THE CATHETER WERE CORRECTLY INSTALLED. THE MANUAL PULLBACK OF THE IMAGING CATHETER WAS WORKING PERFECTLY. NO PATIENT WAS INVOLVED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25996 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) UNK428

    Patients

    Seq Age Sex Outcome Treatment
    1