BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2834056 · Received November 15, 2012

    Report

    Report Number
    9673241-2012-00326
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN ISCHEMIC VENTRICULAR TACHYCARDIA PROCEDURE WHILE ABLATING IN THE RIGHT VENTRICLE A STEAM POP OCCURRED, THEN A PERICARDIAL EFFUSION WAS NOTED. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, THE CATHETER WAS TESTED AND IT PASSED ELECTRICAL, TEMPERATURE AND GENERATOR TESTS. ALSO A DEFLECTION TEST AND AN IRRIGATION TEST WERE PERFORMED AND THE CATHETER PASSED ALL TESTS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO XPRESS SYSTEM: MODEL #: M-4700-01, SERIAL #: (B)(4); COOL FLOW IRRIGATION PUMP: MODEL #: M-5491-02, SERIAL #: (B)(4); STOCKERT RF GENERATOR: MODEL #:M-5463-01, SERIAL #: (B)(4). REGARDING THE BIOSENSE WEBSTER SYSTEMS, THE CUSTOMER WAS CONTACTED BY BWI FIELD SERVICE ENGINEER. THE HOSPITAL EP LAB STAFF ADVISED THAT THIS ISSUE WAS NOT RELATED TO BWI SYSTEMS. THE CUSTOMER DECLINED SYSTEM SERVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ISCHEMIC VENTRICULAR TACHYCARDIA PROCEDURE WHILE ABLATING IN THE RIGHT VENTRICLE A STEAM POP OCCURRED. THERE WAS NO CHANGE IN THE PATIENT'S BLOOD PRESSURE SO THE PROCEDURE WAS CONTINUED. UPON REMOVAL OF THE CATHETERS, A SURFACE ECHO WAS PERFORMED AND A PERICARDIAL EFFUSION WAS DISCOVERED. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS SENT TO ICU IN STABLE CONDITION. A NON-BWI DIAGNOSTIC QUAD CATHETER WAS ALSO IN USE DURING THE PROCEDURE (TYPE OR MANUFACTURER IS UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15697493L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R