BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 2962615 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00511
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: 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 # 2134265-2013-00512, 2134265-2013-00513. IT WAS REPORTED THAT DURING ANGIOPLASTY PROCEDURE, THE ILAB SYSTEM AUTOMATIC PULLBACK STOPPED. DURING THE PROCEDURE THE PHYSICIAN STARTED A MOTOR DRIVE UNIT (MDU) PULLBACK OF THE ILAB SYSTEM. HE NOTICED THAT THE IMAGE DID NOT MOVE AND SLIGHT SQUEALING SOUND CAME FROM THE SLED AND THE PULLBACK STOPPED. THEN HE TRIED ANOTHER PULLBACK AFTER MAKING SURE THE MDU WAS CORRECTLY CONNECTED TO THE SLED. IT WAS UNABLE TO PULLBACK AND THE SQUEALING SOUND GOT LOUDER. THEY DISCONNECTED THE MDU FROM THE SLED AND NOTICED THAT THE SQUEALING SOUND STOPPED. THE PROCEDURE WAS COMPLETED WITH THE MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65714 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1