BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 2982537 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01391
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 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

    (B)(4).DEVICE EVALUATED BY MFR:THE DEVICE WAS RECEIVED FOR ANALYSIS. THE UNIT HAS A MISSING PULLBACK GEAR. THE PROBLEM COULD BE REPRODUCED AS INDICATED IN THE ORIGINAL COMPLAINT. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO MISSING PULLBACK GEAR. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS WEAR AND TEAR.(B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-01393 AND 2134265-2013-01392.IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, PULLBACK ISSUES WERE NOTED.THE 90% STENOSED TARGET LESION WAS LOCATED IN A NON-CALCIFIED AND MODERATELY TORTUOUS MIDDLE LEFT ANTERIOR DESCENDING ARTERY. THE ILAB CART SYSTEM 100V MOTOR DRIVE UNIT (MDU) WAS USED IN CONJUNCTION WITH THE CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT MDU WAS UNABLE TO PULLBACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED. THE PATIENT'S CONDITION IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2013-01393 AND 2134265-2013-01392. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, PULLBACK ISSUES WERE NOTED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A NON-CALCIFIED AND MODERATELY TORTUOUS MIDDLE LEFT ANTERIOR DESCENDING ARTERY. THE ILAB CART SYSTEM 100V MOTOR DRIVE UNIT (MDU) WAS USED IN CONJUNCTION WITH THE CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT MDU WAS UNABLE TO PULLBACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED. THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87119 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 0000006350

    Patients

    Seq Age Sex Outcome Treatment
    1