BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 6198032 · Received December 22, 2016

    Report

    Report Number
    2134265-2016-12193
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 1, 2016
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 2134265-2016-12197 AND 2134265-2016-12198. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED IN CONJUNCTION WITH AN UNSPECIFIED IMAGING CATHETER AND A PULLBACK SLED TO PERFORM AUTOMATIC PULLBACK. HOWEVER, IT WAS REPORTED THAT "IT DIDN'T PULLBACK" AND IT HAD RATTLE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850863 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200 S1004690

    Patients

    Seq Age Sex Outcome Treatment
    1