BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3132478 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03718
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 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

    DEVICE EVALUATED BY MFR: THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. HOWEVER, MOVING SLOWLY THE LEMO CABLE THE UNIT LOOSE IMAGE INTERMITTENTLY WITHOUT EFFECTING THE FUNCTIONALITY OF PULLBACK TEST. THE INTERMITTENT IMAGE WAS CAUSED BY DEFECTIVE LEMO CABLE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#:2134265-2013-03719 AND 2134265-2013-03730. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, PULLBACK WAS UNABLE TO BE PERFORMED. THE LESION WAS LOCATED AT THE PROXIMAL TO MID LAD. THE ILAB INSTL SYSTEM 100V MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH THE CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT DURING PROCEDURE THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#:2134265-2013-03719 AND 2134265-2013-03730. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, PULLBACK WAS UNABLE TO BE PERFORMED. THE LESION WAS LOCATED AT THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. THE ILAB INSTL SYSTEM 100V MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH THE CORONARY CATHETER INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT DURING PROCEDURE THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234149 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100INS0 0000006759

    Patients

    Seq Age Sex Outcome Treatment
    1