BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    MDR report key: 2970376 · Received February 20, 2013

    Report

    Report Number
    2134265-2013-00741
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    IYO
    PMA / PMN Number
    K980851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 2134265-2013-00723 AND 2134265-2013-00742. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, CATHETER PULL BACK DIFFICULTIES OCCURRED. THE PHYSICIAN PLACED A CORONARY CATHETER IN THE LESION AND THEN ATTEMPTED PULLBACK, BUT THE MOTOR DRIVE UNIT DID NOT RETRACT THE CATHETER. THE PROCEDURE OUTCOME WAS NOT KNOWN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73573 GALAXY INTRAVASCULAR ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (SUD) H749A70200

    Patients

    Seq Age Sex Outcome Treatment
    1