BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3103185 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03367
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 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 IS 18 YEARS OLD OR OLDER. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED 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 2134265-2013-03356 AND 2134265-2013-03179. IT WAS REPORTED THAT WHILE IN PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION, THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK. THE 90% STENOSED AND CALCIFIED LESION WAS LOCATED AT THE PROXIMAL RIGHT CORONARY ARTERY, WITH SEVERE TORTUOSITY. THE ILAB INSTL SYSTEM 100V MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH THE CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT IN PREPARATION FOR THE PROCEDURE THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK AND MISSING IMAGE OCCURED. AUTO PULLBACK WAS ATTEMPTED 5 TIMES AND THE PHYSICIAN PERFORMED MANUAL PULLBACK 3 TIMES. THEY REPLACED THE MOTOR DRIVE UNIT, CATHETER AND SLED AND COMPLETED THE PROCEDURE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204140 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1