BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL

    MDR report key: 3925317 · Received July 2, 2014

    Report

    Report Number
    1317056-2014-00044
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 3, 2014
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER INFORMATION RECEIVED FROM (B)(6), CARDIAC CATH LAB MANAGER, THE PATIENT HAD AN MRI ON (B)(6) 2014 WHICH SHOWED "ACUTE INFARCTS IN THE LEFT BASAL GANGLIA, LEFT FRONTAL LOBE AND LEFT PARIETAL LOBE. THE DISTRIBUTION OF INFARCTS SUGGESTS WATERSHED ISCHEMIA WHICH IS USUALLY CAUSED BY HYPOTENSION/HYPOPERFUSION BUT CAN ALSO BE CAUSED BY VASCULITIS OR CAROTID ARTERY OCCLUSION." DHR REVIEW OF THE PACKAGING AND LOTS OBTAINED THROUGH A SHIPPING HISTORY, REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. THERE IS NO INDICATION THAT THE NAVILYST MEDICAL DEVICE MALFUNCTIONED OR IN ANY WAY CONTRIBUTED TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, A CARDIAC CATHETERIZATION PROCEDURE WAS PERFORMED ON (B)(6) 2014 USING A NAVILYST MEDICAL CONVENIENCE KIT. POST-OP (THE FOLLOWING DAY), THE PATIENT WAS LETHARGIC AND HAD A RIGHT FACIAL DROOP. THE PATIENT HAD A NEURO CONSULT AND A HEAD CT THAT WAS NEGATIVE FOR HEMORRHAGE, HOWEVER, AN MRI CONFIRMED THERE WAS A POSSIBLE CLOT CAUSING THE STROKE. PER CONVERSATION WITH THE NAVILYST MEDICAL CLINICAL SPECIALIST, AND THE TECHNICIAN WORKING DURING THE PROCEDURE, THE TECHNICIAN WAS "CONFIDENT THAT NO AIR WAS INJECTED IN THE CORONARIES FROM THE MANIFOLD SYSTEM." SHE FURTHER STATED THAT DR. (B)(6) LOOKED AT THE ANGIOGRAPHIC FILMS AND SAID THEY WERE "CLEAN", AND THAT THERE WAS NO EVIDENCE OF AN AIR EMBOLI DETECTED ON THE IMAGES. THE USED DEVICES WERE DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385444 NAVILYST MEDICAL CONVENIENCE KIT LJS NAVILYST MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R