BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 476453 · Received July 29, 2003

    Report

    Report Number
    MW1029180
    Event Type
    Injury
    Date Received
    July 29, 2003
    Date of Event
    June 26, 2003
    Report Date
    July 28, 2003
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/16/03: ADD'L INFO OBTAINED REVEALED THE PHYSICIAN IS CURRENTLY UNDERGOING ADD'L TRAINING TOWARDS CERTIFICATION FOR THE ANGIO-SEAL STS DEVICE.

    Description of Event or Problem · 1

    AT THE END OF THE CARDIAC CATH ANGIOSEAL WAS USED AS CLOSURE DEVICE FOR RFA. DEVICE WAS INSERTED AND DEPLOYED. MD WAS UNABLE TO REMOVE DEVICE. AFTER ATTEMPTS BY 2 OTHER CARDIOLOGISTS, PT WAS TAKEN TO OR. THE VASOSEAL SEEMED TO HAVE COAGULATED OUTSIDE THE VESSEL, AND THE CATHETER ITSELF WAS TRAPPED INSIDE THE ARTERY. THE SHEATH WAS REMOVED IN TOTAL AFTER THE COMMON DEEP AND SUPERFICIAL FEMORAL VESSELS WERE EXPOSED AND ISOLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST JUDE MEDICAL NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention