BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3101450 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03284
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 10, 2013
    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 THE MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE 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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2013-03177 AND MDR ID # 2134265-2013-03167. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, THE ILAB ULTRASOUND IMAGING SYSTEM MOTORDRIVE WAS UNABLE TO PERFORM PULLBACK. DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, IT WAS NOTED THAT THE MDU OF THE ILAB IMAGING SYSTEM WAS NOT ABLE TO PERFORM PULLBACK. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE THROUGH MANUAL PULLBACK. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203253 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1