BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3575236 · Received January 14, 2014

    Report

    Report Number
    2029046-2014-00010
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    December 20, 2013
    Report Date
    December 19, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON FEBRUARY 16TH OF 2014, BWI REPRESENTATIVE FROM (B)(4) INFORMED US THAT THE INITIAL PRODUCT REPORTED (BRAND NAME: THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER / US CATALOG # BNI35DDH / 510K/PMA: P030031/S025 / LOT # UNKNOWN) IS INCORRECT. THE CORRECT PRODUCT INFORMATION SHOULD BE: BRAND NAME: THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER, US CATALOG # BNI35BDH, 510K/PMA: P030031/S025. THIS INFORMATION HAS BEEN UPDATED ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISPOSED BY THE CUSTOMER. CONCOMITANT BWI PRODUCTS: CARTO 3 SYSTEM, US CATALOG # FG540000. LASSO 2515 NAV VARIABLE CATHETER: US CATALOG # LN122515CT, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    DURING A PULMONARY VEIN ISOLATION PROCEDURE, IT WAS REPORTED THAT A CARDIAC TAMPONADE OCCURRED. APPROXIMATELY 1600 MILLIMETERS WERE REMOVED AND REPLACED. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TAKEN TO THE THEATERS. THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR 2 (TWO) HOURS AND CONDITION IS UNKNOWN. ON (B)(4), RECEIVED ADDITIONAL INFORMATION REQUESTED FROM BWI REPRESENTATIVE STATING THAT ROUGHLY AT THE END OF THE PROCEDURE, IT WAS NOTICED THAT BLOOD PRESSURE SUDDENLY DECREASED AND ON FLUORO THERE WAS A DECREASED ON THE LEFT HEART MOVEMENT. TAMPONADE WAS DIAGNOSED. BLOOD WAS DRAINED AND CARDIOLOGY TEAM WAS CONTACTED FOR SUPPORT AND SURGICAL ADVICE. PATIENT WAS TAKEN TO THEATRE AND A PERFUSION WAS NOTED BETWEEN LEFT SUPERIOR PULMONARY VEIN AND APPENDAGE. THIS WAS REPAIRED WITH STITCHES AND GLUE. PATIENT WAS OUT OF SURGERY AND STABLE. THE PATIENT WILL BE KEPT OVER THE WEEKEND FOR REVIEW. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THIS ADVERSE EVENT IS ANATOMY RELATED, THEREFORE UNRELATED TO PROCEDURE OR DEVICE. APPENDAGE WAS VERY THIN. ROOF WAS VERY TRABECULATED AND DIFFICULT TO REMAIN IN SAME PLACE. IN ADDITION, PATIENT WAS DESCRIBE AS OBESE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35540 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-01-S UNKNOWN_D-1317-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R