BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    MDR report key: 2833944 · Received November 15, 2012

    Report

    Report Number
    9673241-2012-00325
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED, AND WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT BWI PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4); COOL FLOW IRRIGATION PUMP: MODEL #: M-5491-02, SERIAL #: (B)(4); 3. 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 TOWARDS THE END OF AN IDIOPATHIC VT ABLATION PROCEDURE THE PATIENT'S BLOOD PRESSURE DROPPED. ECHO CONFIRMED THAT TAMPONADE OCCURRED. PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 200 CC OF FLUID WAS REMOVED. THE PATIENT WAS STABLE AND UNDER OBSERVATION AT THE TIME THE COMPLAINT WAS REPORTED. THE PHYSICIAN'S OPINION REGARDING THE CAUSALITY OF THE TAMPONADE WAS THE HIGH POWER. THE SETTING WAS POWER AT 35-50 W, AND IRRIGATION FLOW AT 15 ML/MIN. NO DIFFICULTY IN CATHETER MANIPULATION NOR SIGNAL ABNORMALITY WAS OBSERVED PRIOR TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1318-02-S 15506584LB

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R