BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULITIMUM EV INTRODUCER, 19F, 30CM

    MDR report key: 3780681 · Received April 18, 2014

    Report

    Report Number
    2182269-2014-00023
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K140327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    A 19F ULTIMUM EV INTRODUCER WAS SELECTED FOR USE IN A TAVI PROCEDURE. AFTER INSERTING THE DELIVERY SYSTEM, THE HEMOSTATIC VALVE OF THE INTRODUCER WAS NOTED TO BE LEAKING AND THE PT LOST 200ML OF BLOOD. THE PT WAS GIVEN A BLOOD TRANSFUSION. IT WAS NOTED THE TRANSFUSION WAS PROCEDURE RELATED AND NOT NECESSARILY DUE TO THE LEAKAGE OF THE SHEATH. THE PT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238813 ULITIMUM EV INTRODUCER, 19F, 30CM DYB ST. JUDE MEDICAL C407699 4415826

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R