BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 1905207 · Received November 22, 2010

    Report

    Report Number
    9673241-2010-00081
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHYSICIAN STATED THAT THERE WAS NO INDICATION OF ANY MALFUNCTION OF BWI EQUIPMENT DURING THIS PROCEDURE CONCOMITANT BIOSENSE WEBSTER PRODUCTS USED DURING THE PROCEDURE: CARTO XP SYSTEM, MODEL NO.: M-4700-01, (B)(4); COOL FLOW PUMP, MODEL NO.: M-5491-02, (B)(4); STOCKERT 70 SYSTEM, MODEL NO.: M-5463-01, (B)(4). IT WAS REPORTED THAT A PATIENT SUFFERED A PERICARDIAL EFFUSION DURING A ATRIAL FLUTTER ABLATION WHEN THE REPORTED CATHETER WAS IN USE. THE CATHETER WAS TESTED AND PASSED VISUAL, ELECTRICAL, TEMPERATURE BATH, GENERATOR, DEFLECTION AND PATENCY/FLOW TESTS. COMPLAINT CANNOT BE CONFIRMED AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, IT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO HOURS INTO AN ATRIAL FLUTTER ABLATION IT WAS DETERMINED THAT THE PATIENT HAD SUFFERED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS ATTEMPTED BUT NOT SUCCESSFUL. THE PATIENT WAS ADMITTED TO CRITICAL CARE. THE PATIENT HAD BRADYCARDIA BEFORE THE ABLATION PROCEDURE AND WAS CALLED IN THE NEXT DAY AGAIN FOR THE IMPLANTATION OF A PACEMAKER. THIS WAS UNRELATED TO THE ABLATION PROCEDURE.

    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 15208631M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R