BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC IMAGING CATHETER - CORONARY

    MDR report key: 4021449 · Received August 19, 2014

    Report

    Report Number
    2134265-2014-05203
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Report Date
    July 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    DQO
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, PRODUCT INSPECTION COULD NOT BE PERFORMED. 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 2134265-2014-05204 AND 2134265-2014-04940. IT WAS REPORTED THAT MOTOR DRIVE UNIT FAILED TO DO AUTO PULLBACK. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH A CORONARY CATHETER INTENDED TO VISUALIZE THE UNSPECIFIED LESION. DURING PROCEDURE, MOTOR DRIVE UNIT FAILED TO DO AUTOMATIC PULLBACK. HOWEVER, LIQUID CRYSTAL DISPLAY (LCD) FUNCTIONS NORMALLY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497594 ULTRASONIC IMAGING CATHETER - CORONARY CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - FREMONT (SUD) UNK97

    Patients

    Seq Age Sex Outcome Treatment
    1