BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2190486 · Received August 4, 2011

    Report

    Report Number
    2029046-2011-00073
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE THERE WAS A PERICARDIAL EFFUSION. THE EFFUSION WAS CONFIRMED WITH ULTRASOUND AT THE END OF THE CASE. AT THAT TIME THE PHYSICIAN DECIDED THAT IT WAS NOT SEVERE ENOUGH TO WARRANTY INTERVENTION. AFTER THE PATIENT HAD BEEN IN RECOVERY, THE PHYSICIAN CHECKED THE EFFUSION WITH ULTRASOUND AGAIN AND THEN DECIDED TO DRAIN THE FLUID SURGICALLY. THE PATIENT WAS STABLE AND HAD BEEN RELEASED. THE PHYSICIAN STATED THAT THERE WOULD BE NO LONG TERM EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR THERMO TC UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R