BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 2920167 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00337
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 MFR #:2134265-2013-00338 AND 2134265-2012-08542. IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE MOTOR DRIVE UNIT FAILED TO PULLBACK. THE TARGET LESION WAS LOCATED IN AN UNKNOWN VESSEL. THE MOTOR DRIVE UNIT WAS ATTACHED TO THE SLED, AUTOMATIC PULLBACK WAS ATTEMPTED AND FAILED. THE MOTOR DRIVE UNIT WAS ATTACHED TO A SECOND SLED, AUTOMATIC PULLBACK WAS ATTEMPTED AND FAILED. THE MOTOR DRIVE UNIT WAS EXCHANGED FOR ANOTHER, ATTACHED TO THE SAME SLED AND PULLBACK WAS SUCCESSFUL. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26457 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1