BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3971715 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04546
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 7, 2014
    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: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 2134265-2014-04545 AND 2134265-2014-04470. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE INTRAVASCULAR ULTRASOUND (IVUS), AN UNSPECIFIED IMAGING CATHETER AND BSC SLED WAS USED IN CONJUNCTION WITH THE MOTOR DRIVE UNIT (MDU). AFTER THE SLED WAS PLACED ON, AUTOMATIC PULLBACK OPERATION STARTED. HOWEVER, THE MOTOR DRIVE UNIT FAILED TO MOVE BACKWARD. THE PHYSICIAN BELIEVED THERE WAS A PROBLEM WITH THE UNSPECIFIED IMAGING CATHETER AND THE BSC SLED. MANUAL PULLBACK WAS DONE USING ANOTHER IMAGING CATHETER AND SLED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447862 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1