BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 4182414 · Received October 17, 2014

    Report

    Report Number
    2134265-2014-06406
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    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

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED WHICH LOCATED IN THE MILDLY CALCIFIED AND NON TORTUOUS DISTAL RIGHT CORONARY ARTERY.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-06374, 2134265-2014-06405. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS¿ IMAGING CATHETER WAS USED IN CONJUNCTION WITH ILAB ULTRASOUND IMAGING SYSTEM AND A SLED TO PERFORM AUTOMATIC PULLBACK. HOWEVER, IT WAS NOTED THAT PULLBACK FAILURE OCCURRED. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE AFTER THE OPTICROSS¿ IMAGING CATHETER WAS EXCHANGED TO ANOTHER OPTICROSS¿ IMAGING CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661797 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) H749ILAB100CART0 0000006720

    Patients

    Seq Age Sex Outcome Treatment
    1