BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3090580 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-02909
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    IYO
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR:DEVICE NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-02911;2134265-2013-02912. IT WAS REPORTED THAT DURING A CORONARY INTERVENTION, AN AUTOMATIC PULLBACK FAILURE OCCURRED. DURING THE PROCEDURE, THE MDU WAS UNABLE TO PERFORM AUTO PULLBACK. THE PHYSICIAN DID THE MANUAL PULLBACK AND COMPLETE THE PROCEDURE. NO PATIENT COMPLICATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192214 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR IYO BOSTON SCIENTIFIC - FREMONT (CE) UNK71

    Patients

    Seq Age Sex Outcome Treatment
    1