BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 4111596 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05901
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 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

    (B)(4). DEVICE EVALUATED BY MFR: 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 2134265-2014-05632 AND 2134265-2014-05900. IT WAS REPORTED THAT AUTOMATIC PULLBACK FAILURE OCCURRED. DURING A PERCUTANEOUS CORONARY INTERVENTION, AN OPTICROSS IMAGING CATHETER WAS USED TO DIAGNOSE AN UNKNOWN LESION. HOWEVER, THERE WAS A PROBLEM WITH PULLBACK. THEY ATTEMPTED AUTOMATIC PULLBACK TWICE AND AFTER EXCHANGING THE DEVICE TO ANOTHER OF SAME DEVICE, THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591456 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) UNK71

    Patients

    Seq Age Sex Outcome Treatment
    1