BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC CORP

    MDR report key: 648059 · Received November 18, 2005

    Report

    Report Number
    1317056-2005-00064
    Event Type
    Other
    Date Received
    November 18, 2005
    Date of Event
    October 6, 2005
    Report Date
    October 31, 2005
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    "WITH THE FIRST LEFT CORONARY INJECTION, AN AIR EMBOLUS WAS NOTED IN THE CIRCUMFLEX ARTERY. THIS CAUSED PAIN AND ABNORMAL EKG CHANGES. PT TREATED WITH OXYGEN, NITRO (SL, AND IV) AND MORPHINE." AFTER THIS WAS DONE "THE ABNORMAL CARDIAC CHANGES REVERTED TO BASELINE." THE PRODUCTS HAVE BEEN DISPOSED BY THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP CONVENIENCE KIT DTL BOSTON SCIENTIFIC/NAMIC NA 1052839

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R