BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3122341 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03543
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY THE MANUFACTURER: THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, PRODUCT INSPECTION COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-03509, 2134265-2013-03510. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) DEMONSTRATION PROCEDURE FOR THE USAGE OF THE ILAB, PULLBACK FAILURE OCCURRED. THE ILAB CART SYSTEM 120V MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH ATLANTIS SR PRO IMAGING CATHETER DURING THE DEMONSTRATION. WHEN THE PHYSICIAN PERFORMED AN AUTOMATIC PULLBACK THE SYSTEM FAILED TO PULLBACK. THREE AUTOMATIC PULLBACK ATTEMPTS WERE ALL UNSUCCESSFUL. THE MOTOR DRIVE UNIT WAS REPOSITIONED BUT IT DID NOT MOVE. THE DEMONSTRATION WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223959 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1