BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3024230 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01832
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 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

    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:2134265-2013-01831;2134265-2013-01869; 2134265-2013-02505. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE MDU WAS UNABLE TO PULLBACK THE IMAGING CATHETER. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. AN ATLANTIS SR PRO2 CATHETER WAS SELECTED AND ADVANCED TO THE TARGET LESION HOWEVER, THE MDU OF THE ILAB SYSTEM STOPPED DURING THE PROCEDURE. THE IMAGING CATHETER WAS THEN EXCHANGED WITH ANOTHER OF THE SAME CATHETER. UPON ADVANCING OF THE SECOND IMAGING CATHETER TOWARDS THE LESION, THE PULLBACK STOPPED AT ABOUT 70MM. THE PROCEDURE WAS THEN COMPLETED USING THE GALAXY2 SYSTEM WITH THE 2ND IMAGING CATHETER. NO COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126556 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1