BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3110780 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03340
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 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

    DEVICE EVALUATED BY MANUFACTURER: 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

    THE SAME CASE AS MDR # 2134265-2013-03170, 2134265-2013-03169. IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND (IVUS) PROCEDURE, MOTOR DRIVE UNIT AUTOMATIC PULLBACK FAILED. DURING THE IVUS PROCEDURE, MOTOR DRIVE UNIT DID NOT PULLBACK AUTOMATICALLY. THE PHYSICIAN TRIED RECONNECTING THE MOTOR DRIVE UNIT TO THE SLED SEVERAL TIMES, THE SAME RESULT WAS OBTAINED. THE CASE WAS FINISHED WITH A MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213257 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1