BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 2870799 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-08210
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    OBJ
    PMA / PMN Number
    K051679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE OBSERVED WITH NO VISIBLE DAMAGE OR DEFECTS. THE DEVICE MEETS SPECIFICATIONS FOR FUNCTIONAL TEST AND SUCCESSFULLY UNDERWENT A CONTINUOUS BURN-IN FOR 6 HOURS. THE REPORTED PROBLEM COULD NOT BE REPRODUCED AS INDICATED IN THE COMPLAINT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND DIAGNOSIS PROCEDURE, THE ILAB ULTRASOUND IMAGING SYSTEM MOTORDRIVE AUTOMATIC PULLBACK FUNCTION STOPPED WORKING DURING THE PROCEDURE. THE MANUAL PULLBACK OF THE IMAGING CATHETER WAS PERFORMED WHICH DID NOT GIVE GOOD RESULT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTRAVASCULAR ULTRASOUND DIAGNOSIS PROCEDURE, THE ILAB ULTRASOUND IMAGING SYSTEM MOTORDRIVE AUTOMATIC PULLBACK FUNCTION, STOPPED WORKING DURING THE PROCEDURE. THE MANUAL PULLBACK OF THE IMAGING CATHETER WAS PERFORMED WHICH DID NOT GIVE GOOD RESULT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB240INS0 0000006171

    Patients

    Seq Age Sex Outcome Treatment
    1