BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC - CELSIUS THERMOCOOL TC

    MDR report key: 2190271 · Received August 4, 2011

    Report

    Report Number
    2029046-2011-00071
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM: MODEL #: M-4800-01, (B)(4). COOL FLOW IRRIGATION PUMP: MODEL #: M-5491-02, (B)(4). STOCKERT RF GENERATOR: MODEL #:M-5463-01, (B)(4). THE CUSTOMER STATED THAT THERE WAS NO DEFICIENCY WITH BIOSENSE WEBSTER PRODUCTS OR EQUIPMENTS. THE CUSTOMER ALSO DECLINED SERVICE REQUESTS WHEN CONTACTED BY BW FIELD SERVICE ENGINEER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER PROCEDURE A PERICARDIAL EFFUSION OCCURRED. THE EFFUSION WAS NOTICED AFTER THE ABLATION. ATRIAL FLUTTER RHYTHM WAS TERMINATED DUE TO ABLATION LESION CONDUCTION BLOCK ACROSS THE CAVOTRICUSPID ISTHMUS. DURING THE PROCEDURE CARDIAC PRESSURES SLOWLY BEGAN TO DROP. IT WAS OBSERVED THAT THE DROP IN BLOOD PRESSURE PERSISTED. PERICARDIAL EFFUSION WAS IDENTIFIED BY TRANSTHORACIC ECHO, NOTING THAT THE EFFUSION INCREASED RESULTING IN TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED. PATIENT STAYED OVERNIGHT FOR EVALUATION. PATIENT RECOVERED VERY WELL WITH NO OTHER ISSUES AND WAS FEELING GREAT. PATIENT'S ATRIAL FLUTTER ABLATION WAS A SUCCESS AND PATIENT'S EJECTION FRACTION HAS IMPROVED DUE TO PROCEDURE. PATIENT'S PROGNOSIS WAS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERIC - CELSIUS THERMOCOOL TC CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) CELSIUS THERMO TC UNKNOWN_CELSIUS THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R