BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC IMAGING CATHETER - CORONARY

    MDR report key: 3971390 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04617
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 8, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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: 2134265-2014-04501, 2134265-2014-04618. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING PREPARATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS NOTED THAT THE AUTOMATIC PULLBACK WAS NOT WORKING. THE BSC IMAGING CATHETER WAS CHANGED THEN A SIMULATOR WAS USED AND THE SYSTEM WAS REBOOTED, HOWEVER, THE PROBLEM WAS NOT RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448397 ULTRASONIC IMAGING CATHETER - CORONARY CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) UNK97

    Patients

    Seq Age Sex Outcome Treatment
    1