BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3192449 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04357
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION 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

    SAME CASE AS MDR ID 2134265-2013-04356, MDR ID 2134265-2013-04358. IT WAS REPORTED THAT DURING TEST RECORDING, AN AUTOMATIC PULLBACK FAILURE OCCURRED. THE MD5 MOTORDRIVE UNIT WAS USED IN CONJUNCTION WITH A BSC CATHETER DURING TEST RECORDING. DURING SERVICING, WHEN THE ATTEMPT WAS MADE TO PERFORM AUTOMATIC PULLBACK, THE SYSTEM FAILED TO PULLBACK. IT WAS NOTED THAT AUTOMATIC PULLBACK WAS REPEATED SEVERAL TIMES BUT THE SAME PROBLEM OCCURRED. MANUAL PULLBACK WAS ALSO PERFORMED, STILL THE PROBLEM PERSISTED. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292866 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1