BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3103173 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03178
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR EVALUATION. THE PRODUCT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE EXTERNAL DAMAGE OR DEFECTS OBSERVED. THE REPORTED EVENT IS A KNOWN AND ANTICIPATED FAILURE MODE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORD OF THE COMPLAINT DEVICE COULD NOT BE REVIEWED .THE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE S MDR ID: 2134265-2013-3168;2134265-2013-03335. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, AN AUTOMATIC PULLBACK FAILURE OCCURRED. THE ILAB CART SYSTEM 100V WITH MOTOR DRIVE WAS USED IN CONJUNCTION WITH AN ATLANTIS SR PRO2 CATHETER INTENDED TO VISUALIZE THE TARGET LESION. IT WAS NOTED THAT DURING POST IVUS THE MDU WAS UNABLE TO PERFORM AUTOMATIC PULLBACK. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SAME CATHETER USING MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204136 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0

    Patients

    Seq Age Sex Outcome Treatment
    1