BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMUM HEMOSTASIS INTRODUCER, 6F, 12CM SHEATH

    MDR report key: 2212664 · Received August 10, 2011

    Report

    Report Number
    2182269-2011-00129
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K001346
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. AN EVALUATION SUMMARY WILL BE INCLUDED WITH THE FINAL REPORT.

    Description of Event or Problem · 1

    A 6F ULTIMUM INTRODUCER WAS USED DURING A CRYOABLATION PROCEDURE ON A PATIENT WITH PAROXYSMAL ATRIAL FIBRILLATION. THIRTY MINUTES INTO THE PROCEDURE, THE PHYSICIAN NOTICED AIR IN THE SYRINGE WHEN ASPIRATING BLOOD FROM THE INTRODUCER AND DECIDED TO CHANGE THE INTRODUCER. THE CATHETER WAS PULLED OUT AND A J-WIRE WAS INSERTED IN IT WITH NO PROBLEMS. WHEN THE PHYSICIAN TRIED TO PULL OUT THE INTRODUCER, IT BROKE AT THE PROXIMAL END OF THE SHEATH, ABOUT 1CM DISTAL TO THE HUB. A PIECE ABOUT 11CM LONG WAS STUCK IN THE GROIN AND THE PHYSICIAN WAS NOT ABLE TO PULL IT OUT. THE PHYSICIAN DECIDED TO FINISH THE PROCEDURE AND A VASCULAR SURGEON WAS CONSULTED TO HELP. A CT WAS DONE TO LOCATE THE PIECE. ANOTHER OPERATION WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS HOSPITALIZED DUE TO THIS EVENT. THE PATIENT IS NOW STABLE AND RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMUM HEMOSTASIS INTRODUCER, 6F, 12CM SHEATH INTRODUCER DEVICE DYB ST. JUDE MEDICAL NA 3339866

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R