BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOGA-STAR

    MDR report key: 228225 · Received June 9, 1999

    Report

    Report Number
    2020638-1999-00014
    Event Type
    Injury
    Date Received
    June 9, 1999
    Date of Event
    May 11, 1999
    Report Date
    May 20, 1999
    Manufacturer
    CORDIS WEBSTER, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A "NOGA" MAPPING PROCEDURE WAS PERFORMED ON AN EIGHTY-SIX (86) YEAR OLD FEMALE PT. UPON COMPLETION OF THE MAPPING PROCEDURE, THE PT BECAME HYPOTENSIVE. APPROPRIATE MEDICATIONS WERE GIVEN BUT THE HYPOTENSION PERSISTED. AN ECHOCARDIOGRAM REVEALED A POSTERIOR PERFORATION OF THE LEFT VENTRICLE AND A SMALL EFFUSION. CONSEQUENTLY, A PERICARDIOCENTESIS WAS PERFORMED AND APPROX 100 CC OF FLUID WAS REMOVED. THE PT RECOVERED AND WAS DISCHARGED FROM THE HOSP TWO DAYS LATER WITH NO FURTHER SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOGA-STAR MAPPING CATHETER DQO CORDIS WEBSTER, INC. D-1207-06-S NI

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention