BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3133167 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03737
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 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 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 AS MDR ID#: 2134265-2013-03726 AND 2134265-2013-03732. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), PULLBACK STOPPED. ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. AN ILAB CART SYSTEM 100V MOTOR DRIVE UNIT (MDU) WAS USED IN CONJUNCTION WITH THE CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. WHEN STARTING TO PERFORM PULLBACK, AN ABNORMAL SOUND WAS HEARD FROM THE MDU AND THE PULLBACK WAS STOPPED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED. THE PATIENT'S CONDITION STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235326 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1