BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR DIAGNOSTIC ELECTRODE CATHETER

    MDR report key: 119112 · Received September 12, 1997

    Report

    Report Number
    2020638-1997-00007
    Event Type
    Injury
    Date Received
    September 12, 1997
    Date of Event
    July 29, 1997
    Report Date
    September 12, 1997
    Manufacturer
    CORDIS WEBSTER, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A CORONARY ANGIOGRAPHY PROCEDURE AND STABILIZATION OF THE PT, THE LEFT VENTRICLE WAS EVALUATED BY THE BIOSENSE TECHNIQUE. WITHIN ONE HR AFTER COMPLETING THE DIAGNOSTIC STUDY, THE PT WAS HYPOTENSIVE. AN ECHOCARDIOGRAM CONFIRMED THE PRESENSE OF PERICARDIAL EFFUSION WITH TAMPONADE. THE PT WAS TREATED WITH SUCCESSFUL TRANSTHORACIC PERCARDIOCENTESIS. THE PT WAS MONITORED OVERNIGHT WIGHOUT COMPLICATIONS AND WAS DISCHARGED ON THE SECOND DAY AFTER THE EVENT WITHOUT SYMPTOMS OR SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR DIAGNOSTIC ELECTRODE CATHETER CORDIS WEBSTER ELECTRODE CATHETER DRF CORDIS WEBSTER, INC. NA 609376

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention