BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILAB ULTRASOUND IMAGING SYSTEM

    MDR report key: 3834252 · Received May 28, 2014

    Report

    Report Number
    2134265-2014-03245
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 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: 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: 2134265-2014-03006 AND 2134265-2014-03246. IT WAS REPORTED THAT PULLBACK FAILURE OCCURRED. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH AN OPTICROSS¿ CORONARY CATHETER INTENDED TO VISUALIZE THE AN UNSPECIFIED LESION. DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), PULLBACK BECAME UNABLE TO BE PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312586 ILAB ULTRASOUND IMAGING SYSTEM CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC - FREMONT (CE) UNK71

    Patients

    Seq Age Sex Outcome Treatment
    1