BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC IMAGING CATHETER - CORONARY

    MDR report key: 3925452 · Received July 10, 2014

    Report

    Report Number
    2134265-2014-04145
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED.  THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-03970, 2134265-2014-04144. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. A 100V GALAXY 2 SYSTEM WAS USED IN CONJUNCTION WITH AN UNSPECIFIED BSC IMAGING CATHETER IN AN UNKNOWN PROCEDURE. THE PHYSICIAN USED THE MOTOR DRIVE UNIT 5 TO PERFORM PULLBACK HOWEVER IT FAILED TO PERFORM AUTOMATIC PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403808 ULTRASONIC IMAGING CATHETER - CORONARY CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) UNK97

    Patients

    Seq Age Sex Outcome Treatment
    1