BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 3103090 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03008
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR EVALUATION. THE RETURNED PULLBACK SLED APPEARS NORMAL AND NO DAMAGE WAS OBSERVED. THE SLED WORKED PROPERLY AND WAS ABLE TO PULLBACK DURING A FUNCTIONAL TESTING WITH A TEST CATHETER. NO ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS. THE DEVICE DID NOT FAIL TO MEET SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OLDER 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 # 2134265-2013-03007, 2134265-2013-03009. IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AN AUTOMATIC PULLBACK FAILURE OCCURED. THE TARGET LESION BEING TREATED WAS LOCATED AT THE LEFT MAIN CORONARY ARTERY. DURING INTRAVASCULAR ULTRASOUND (IVUS), AN ATTEMPT WAS MADE TO DO AN AUTOMATIC PULLBACK. THE MOTOR DRIVE COGS WERE ABLE TO START UP HOWEVER, THE SLED WAS NOT ACTUALLY RETRACTING THE CATHETER. THE MOTOR DRIVE UNIT WAS DISCONNECTED. AND WAS RECONNECTED BACK TO THE SLED TO SECURE THE CONNECTION, BUT THE PULLBACK WAS STILL UNSUCCESSFUL. THE SLED WAS THEN REMOVED AND A MANUAL PULLBACK WAS DONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS MDR # 2134265-2013-03007, 2134265-2013-03009. IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, AN AUTOMATIC PULLBACK FAILURE OCCURED. THE TARGET LESION BEING TREATED WAS LOCATED AT THE LEFT MAIN CORONARY ARTERY. DURING INTRAVASCULAR ULTRASOUND (IVUS), AN ATTEMPT WAS MADE TO DO AN AUTOMATIC PULLBACK. THE MOTOR DRIVE COGS WERE ABLE TO START UP HOWEVER, THE SLED WAS NOT ACTUALLY RETRACTING THE CATHETER. THE MOTOR DRIVE UNIT WAS DISCONNECTED. AND WAS RECONNECTED BACK TO THE SLED TO SECURE THE CONNECTION, BUT THE PULLBACK WAS STILL UNSUCCESSFUL. THE SLED WAS THEN REMOVED AND A MANUAL PULLBACK WAS DONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204125 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200 S1002442

    Patients

    Seq Age Sex Outcome Treatment
    1