BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3241212 · Received July 22, 2013

    Report

    Report Number
    2134265-2013-05144
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    SAME CASE AS MDR ID 2134265-2013-05142, 2134265-2013-05143, 2134265-2013-05145. IT WAS REPORTED THAT DURING INTRAVASCULAR ULTRASOUND PROCEDURE, FAILURE TO PULLBACK OCCURRED. THE PHYSICIAN USED AN ILAB CART SYSTEM 240 WITH A BSC IMAGING CATHETER AND TWO SLEDS. DURING THE PROCEDURE, WHEN THE ATTEMPT WAS MADE TO PERFORM AUTOMATIC PULLBACK, THE SYSTEM FAILED TO PULLBACK. IT WAS NOTED THAT THE PHYSICIAN ATTEMPTED AUTOMATIC PULLBACK ONLY ONCE THEN CHANGED TO ANOTHER SLED BUT THE SAME PROBLEM PERSISTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341845 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1