BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3

    MDR report key: 3133144 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03726
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    IYO
    PMA / PMN Number
    K072517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE PRODUCT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE EXTERNAL DAMAGE OR DEFECTS OBSERVED. THE MDU-5 WAS INSTALLED INTO A GOLD STANDARD SYSTEM AND TESTED FOR FUNCTIONALITY; THE UNIT MEETS SPECIFICATION. THE UNIT UNDERWENT A 4 HOUR BURN-IN WITHOUT ANY FAILURES OBSERVED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-03732 AND 2134265-2013-03737. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), PULLBACK STOPPED. ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. AN ILAB CART SYSTEM 100V MOTOR DRIVE UNIT (MDU) WAS USED IN CONJUNCTION WITH THE CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. WHEN STARTING TO PERFORM PULLBACK, AN ABNORMAL SOUND WAS HEARD FROM THE MDU AND THE PULLBACK WAS STOPPED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED. THE PATIENT'S CONDITION STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234592 ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CARTD0 0000006820

    Patients

    Seq Age Sex Outcome Treatment
    1