BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3955129 · Received July 24, 2014

    Report

    Report Number
    2134265-2014-04386
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE UNIT WAS RECEIVED IN GOOD CONDITION WITH NO VISIBLE DAMAGE OR DEFECTS OBSERVED. THE UNIT MEETS SPECIFICATIONS. IN ADDITION, THE UNIT SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN FOR FOUR HOURS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-04391 AND 2134265-2014-04389. IT WAS REPORTED THAT AUTO PULLBACK FAILED. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH A BSC CORONARY IMAGING CATHETER INTENDED TO VISUALIZE THE UNSPECIFIED LESION. DURING PERCUTANEOUS CORONARY INTERVENTION, AN INTRAVASCULAR ULTRASOUND WAS PERFORMED BUT THE MOTOR DRIVE UNIT FAILED TO PERFORM PULLBACK AND COULD ONLY DO A MANUAL PULLBACK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY PERFORMING A MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-04391 AND 2134265-2014-04389. IT WAS REPORTED THAT AUTO PULLBACK FAILED. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH A BSC CORONARY IMAGING CATHETER INTENDED TO VISUALIZE THE UNSPECIFIED LESION. DURING PERCUTANEOUS CORONARY INTERVENTION, AN INTRAVASCULAR ULTRASOUND WAS PERFORMED BUT THE MOTOR DRIVE UNIT FAILED TO PERFORM PULLBACK AND COULD ONLY DO A MANUAL PULLBACK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY PERFORMING A MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434118 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) UNK71

    Patients

    Seq Age Sex Outcome Treatment
    1