BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR DIAGNOSTIC/ABLATION CATHETER

    MDR report key: 1081584 · Received July 24, 2008

    Report

    Report Number
    9673241-2008-00034
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 4, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    P990025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT THE NAVISTAR CATHETER WILL NOT BE RETURNED TO BIOSENSE WEBSTER FOR EVAL.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT CARDIAC TAMPONADE OCCURRED WHILE ABLATION WAS BEING PERFORMED ON A PAROXYSMAL ATRIAL FIBRILLATION PT. AFTER ISOLATION OF LEFT AND RIGHT PULMONARY VEINS, THE PHYSICIAN WENT BACK TO THE LEFT PULMONARY VEINS AND CONTINUED THE ISOLATION. AFTER APPROXIMATELY SIX ABLATION POINTS ON THE LEFT SIDE, THE PATIENT'S BLOOD PRESSURE DECREASED FROM 100 TO AROUND 80, PERICARDIAL EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAPHY, AND THE PROCEDURE WAS STOPPED. THE PT WAS MONITORED FOR AN HOUR AND A HALF, THE BLOOD PRESSURE RECOVERED AND IT WAS CONFIRMED BY ECHOCARDIOGRAPHY THAT THE PERICARDIAL EFFUSION HAD STOPPED. THE PT WAS RELEASED FROM THE OPERATING ROOM AND WAS IN STABLE CONDITION. THE PROGNOSIS FOR THE PT WAS DESCRIBED AS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR DIAGNOSTIC/ABLATION CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1183-07-S 13296805

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening CARTO MAPPING SYSTEM| LASSO CATHETER