BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 2149948 · Received July 5, 2011

    Report

    Report Number
    2029046-2011-00057
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT BWI PRODUCT USED DURING THE PROCEDURE WAS: EZ STEER THERMOCOOL SF NAV CATHETER (PRODUCT NOT MARKETED IN THE US): MODEL #: D-1317-05-S, LOT#: 15307408L. OTHER NON-BWI PRODUCTS USED DURING THE PROCEDURE WERE: AGILIS SHEATH, BRK 1 NEEDLE, BARD FIXED DECA (QUANTITY: 2). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER MAPPING AND ABLATING THE ATRIAL FLUTTER ON THE RIGHT SIDE AND PULMONARY VEIN ISOLATION FOR AFIB IN THE LEFT ATRIUM, THE ANESTHETIST NOTICED PATIENT'S BLOOD PRESSURE DROPPING AND PERICARDIAL EFFUSION WAS NOTICED ON INVESTIGATION CARDIAC ECHO AND TOE. THE PHYSICIAN PROCEEDED TO DRAIN THE PERICARDIUM AND CPR WAS ADMINISTERED WHEN CARDIAC OUTPUT WAS LOST. RIGHT ATRIUM WAS MAPPED AND CTI ABLATION WAS PERFORMED USING THE SAME ABLATION CATHETER PREVIOUS TO LA BEING MAPPED. AFTER BEING STABILIZED THE PATIENT WAS SENT TO OPERATION ROOM FOR REPAIRING THE HEART SURGICALLY. SURGEON NOTED TWO AREAS FOR REPAIR, BEHIND LEFT UPPER PULMONARY VEIN AND AT VENTRICULAR APEX (VENTRICULAR DAMAGE IS BELIEVED TO HAVE HAPPENED DURING PERICARDIAL DRAINAGE PROCEDURE AS VENTRICLE WAS NOT MAPPED OR ANY CATHETERS PLACED HERE AT ANY POINT DURING THE PROCEDURE). HAVING ABLATED OVER THE SAME AREA TOO MANY TIMES, THE PHYSICIAN BELIEVES THIS EVENT WAS PROCEDURE RELATED AND DOES NOT BELIEVE THE CATHETER WAS DIRECTLY RESPONSIBLE FOR THE TAMPONADE. PATIENT WAS IN ITU FOLLOWING THE PROCEDURE. TWO DAYS FOLLOWING THE PROCEDURE, THE PATIENT SEEMED FINE. PATIENT IS EXPECTED TO MAKE FULL RECOVERY. ABLATION WAS DONE USING STOCKERT RF GENERATOR AT 30 AND 35 WATTS, 30 WATTS ONLY USED ON POSTERIOR WALL (INCLUDING AREA WHERE PROBLEM FOUND).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1290-01-S UNKNOWN_D-1290-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR