BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3956219 · Received July 24, 2014

    Report

    Report Number
    2134265-2014-04370
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: UPN SEARCH - CORRECTED FROM H749ILAB120INS0 - ILAB INSTL BASIC SYSTEM 120V TO H749ILAB120CART0 - ILAB CART SYSTEM 120V. DEVICE UPN # - CORRECTED FROM H749ILAB120INS0 TO H749ILAB120CART0. DEVICE LOT # - CORRECTED FROM UNKNOWN LOT TO 0000004856. BATCH EXPIRATION DATE - CORRECTED FROM UNKNOWN DATE TO 02/02/2035. BATCH MANUFACTURED DATE - CORRECTED FROM UNKNOWN DATE TO 09/25/2007. DEVICE EVALUATED BY MANUFACTURER: THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE UNIT MEETS SPECIFICATIONS FOR FUNCTIONAL TEST. IN ADDITION, THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN OVERNIGHT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: OVER 80. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-04429, 2134265-2014-04430. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE LESS THAN 6 MM SQUARED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN ARTERY. DURING INTRAVENOUS ULTRASOUND (IVUS) PROCEDURE, IT WAS NOTED THAT THE MOTOR DRIVE UNIT (MDU) WAS UNABLE TO PERFORM AUTOMATIC PULLBACK. THE LCD DISPLAY APPEARS NORMAL. MANUAL PULLBACK WAS THEN PERFORMED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-04429, 2134265-2014-04430. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. THE LESS THAN 6 MM SQUARED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN ARTERY. DURING INTRAVENOUS ULTRASOUND (IVUS) PROCEDURE, IT WAS NOTED THAT THE MOTOR DRIVE UNIT (MDU) WAS UNABLE TO PERFORM AUTOMATIC PULLBACK. THE LCD DISPLAY APPEARS NORMAL. MANUAL PULLBACK WAS THEN PERFORMED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434461 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB120CART0 0000004856

    Patients

    Seq Age Sex Outcome Treatment
    1