BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3477645 · Received November 19, 2013

    Report

    Report Number
    2134265-2013-08549
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    October 28, 2013
    Report Date
    October 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(6). 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: 2134265-2013-08536 AND 2134265-2013-08533. IT WAS REPORTED THAT MOTOR DRIVE UNIT (MDU) AUTOMATIC PULLBACK FAILURE OCCURRED. DURING THE PROCEDURE, AN ILAB WAS USED IN CONJUNCTION WITH AN ATLANTIS SR PRO IMAGING CATHETER. ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE PHYSICIAN PERFORMED PULLBACK. IT WAS NOTED THAT THE AUTOMATIC PULLBACK FUNCTION OF THE MDU DID NOT WORK AND MANUAL PULLBACK WAS ATTEMPTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MDU. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE AND SAFE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598243 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1