BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2063580 · Received April 19, 2011

    Report

    Report Number
    9673241-2011-00034
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 3500A SUPPLEMENTAL WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. BWI CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, U.S. CATALOG NUMBER: M480001, SERIAL NUMBER: (B)(4). COOLFLOW IRRIGATION PUMP, U.S. CATALOG NUMBER: CFP002, SERIAL NUMBER: (B)(4). STOCKERT 70 RF GENERATOR, U.S. CATALOG NUMBER: S7001, SERIAL NUMBER: (B)(4). LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER, U.S. CATALOG NUMBER: D7L202515RT, LOT NUMBER: 15289133L. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED CATHETER WAS TESTED AND PASSED ELECTRICAL TEST, TEMPERATURE BATH TEST, AND GENERATOR TEST. THE ELECTRICAL LEAKAGE AND RESISTANCE PASSED SPECIFICATION. THE THERMOCOUPLE SENSOR PERFORMED TO SPECIFICATION WHEN IMMERSED IN FLUID WITH CONTROLLED TEMPERATURE. THE CATHETER INTERFACED WITH THE STOCKERT GENERATOR OBTAINING ACCEPTABLE RESULTS. PATENCY TEST WAS PERFORMED AND FAILED SINCE THE CATHETER WAS NOT IRRIGATING FROM FOUR TIP DOME HOLES; THE OTHER TWO WERE IRRIGATING FINE. STEAM POPS ARE GENERALLY ASSOCIATED WITH EXCESSIVE RF ENERGY APPLICATION. EXCESSIVE RF ENERGY DELIVERY CAN BE CAUSED BY A RAPID POWER RAMPING OR EXTENDED RF APPLICATION TO A SINGLE AREA OR BY FAILING TO PROPERLY LIMIT POWER DELIVERY FOR THE TARGET TISSUE. THE CAUSE OF THE REPORTED EVENT DOES NOT APPEAR TO BE MANUFACTURING RELATED AS THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING ABLATION ON RIGHT ATRIAL FLUTTER LINE DURING A-FIB PROCEDURE, A STEAM POP OCCURRED. NO TEMPERATURE OR IMPEDANCE SPIKES WERE NOTED. FLUOROSCOPY CONFIRMED PERICARDIAL EFFUSION. THERE WAS NO DROP IN BLOOD PRESSURE SEEN. PERICARDIOCENTESIS WAS PERFORMED RESULTING IN APPROXIMATELY 600CC OF FLUID BEING REMOVED FROM THE PERICARDIAL SPACE. PATIENT WAS MOVED TO ICU FOR ONE DAY. PATIENT PROGNOSIS IS SATISFACTORY AND HAS FULLY RECOVERED. CAUSALITY OF ADVERSE EVENT IS PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 15328511M

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R