BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3103171 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03335
    Event Type
    Malfunction
    Date Received
    May 9, 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

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: 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 S MDR ID: 2134265-2013-3168;2134265-2013-03178. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, AN AUTOMATIC PULLBACK FAILURE OCCURRED. THE ILAB CART SYSTEM 100V WITH MOTOR DRIVE WAS USED IN CONJUNCTION WITH AN ATLANTIS SR PRO2 CATHETER INTENDED TO VISUALIZE THE TARGET LESION. IT WAS NOTED THAT DURING POST IVUS THE MDU WAS UNABLE TO PERFORM AUTOMATIC PULLBACK. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SAME CATHETER USING MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204204 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1