BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOGA-STAR CATHETER

    MDR report key: 230338 · Received June 26, 1999

    Report

    Report Number
    2020638-1999-00015
    Event Type
    Death
    Date Received
    June 26, 1999
    Report Date
    May 22, 1999
    Manufacturer
    CORDIS WEBSTER, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A NOGA MAPPING PROCEDURE WAS PERFORMED ON AN 84 YR OLD MALE PT. THE PT SUFFERED A STROKE DURING THE PROCEDURE EVEN THOUGH THE MAPPING WAS A SUCCESS. ACCORDING TO THE PHYSICIAN, THE PT HAD BAD CORONARY DISEASE AND IN THE COURSE OF ADVANCING THE CATHETER, PLAQUES WERE DISRUPTED IN THE AORTA. IT WAS THE DECISION OF THE FAMILY TO NOT PROLONG THE PT'S LIFE. PT EXPIRED TWO DAYS AFTER THE MAPPING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOGA-STAR CATHETER MAPPING CATHETER DRF CORDIS WEBSTER, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death