BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR DIAGNOSTIC ELECTRODE CATHETER

    MDR report key: 116635 · Received September 2, 1997

    Report

    Report Number
    2020638-1997-00006
    Event Type
    Injury
    Date Received
    September 2, 1997
    Date of Event
    July 29, 1997
    Report Date
    September 2, 1997
    Manufacturer
    CORDIS WEBSTER, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC CORONARY ANGIOGRAPHY PROCEDURE AND STABILIZATION OF THE PT, THE LEFT VENTRICLE WAS EVALUATED BY THE BIOSENSE NOGA TECHNIQUE. WITHIN 30 MINUTES OF COMPLETING THE NOGA DIAGNOSTIC PROCEDURE, THE PT COMPLAINED OF CHEST BURNING, SHORTNESS OF BREATH, AND LIGHT HEADEDNESS WITH SEVERE HYPOTENSION. AN ECHOCARDIOGRAM CONFIRMED PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. A TRANSTHORACIC PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY SIGNS OF SEVERE CONGESTIVE HEART FAILURE/PULMONARY EDEMA. AN INTRAAORTIC BALLOON PUMP WAS INSERTED AND INTUBATION WAS REQUIRED. OVER THE NEXT 24 HRS THE PT CONTINUED TO IMPROVE WITH AGGRESSIVE MEDICAL THERAPY AND THE BALLOON PUMP WAS REMOVED. THE PT WAS EXTUBATED; HOWEVER, THE PT THEN DEVELOPED ARTERIAL THROMBOSIS AT THE SITE OF THE BALLOON PUMP CATHETER PLACEMENT REQUIRING THROMBECTOMY. SEVERAL HRS LATER, THE PT SUSTAINED A MASSIVE ANTERIOR MYOCARDIAL INFARCTION AND IMMEDIATELY LAPSED INTO PROFOUND CARDIOGENIC SHOCK FOLLOWED BY DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R 1.LIDOCAINE 2% 7/29/97 BALLOON 2.5MM| 2. HEXABRIX 120CC, HEXABRIX 120CC, HEXABRIX 25CC| 3. GUIDING CATHETER 7FJL4SH, GUIDEWIRE 0.14 IN.