BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3042810 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02284
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 UNDETERMINABLE. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2013-02183, MDR ID 2134265-2013-02283. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, FAILURE TO PULLBACK OCCURRED. WHILE USING AN ILAB CART SYSTEM 120V, THE PHYSICIAN SELECTED ATLANTIS SR PRO BUT THE MOTOR DRIVE UNIT DID NOT RECOGNIZED THE CATHETER AND WAS UNABLE TO PERFORM THE AUTOMATIC PULLBACK. AS A RESULT, THE PHYSICIAN USED MANUAL PULLBACK TO COMPLETE THE PROCEDURE. IT HAS BEEN NOTED THAT NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146751 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1