BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2736410 · Received September 8, 2012

    Report

    Report Number
    9673241-2012-00246
    Event Type
    Death
    Date Received
    September 8, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 16, 2012
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, ON A PATIENT WITH VARYING VITAL SIGNS, THE PATIENT'S BLOOD PRESSURE DROPPED AND A PERICARDIAL EFFUSION OCCURRED. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF HIGH BLOOD PRESSURE AND TACHYCARDIA. THE CASE WAS ABORTED AND THE PATIENT EXPIRED. 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, GENERATOR, IRRIGATION AND DEFLECTION 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. SINCE THE CATHETER PASSED SPECIFICATIONS, THE ROOT CAUSE OF THE EFFUSION REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM US CATALOG #: FG540000 SERIAL #: (B)(4); STOCKERT 70 SYSTEM US CATALOG #: S7001 SERIAL #: (B)(4); COOL FLOW PUMP US CATALOG #: CFP002 SERIAL #: (B)(4); SOUNDSTAR 3D 10F-90 US CATALOG #: SNDSTR10 OEM LOT #: 51071113; CORONARY SINUS CATHETER US CATALOG AND LOT #: UNKNOWN; TRANSEPTAL NEEDLE US CATALOG #: FND01902 OEM LOT #: S38817; PREFACE SHEATH US CATALOG #: 301803M OEM LOT #: 15628964; C3 NAV VARIABLE LASSO US CATALOG # LN222515CT LOT #: UNKNOWN. (B)(4). THE ECHO WAS UNREMARKABLE, WITH NO NOTICE OF ANY TAMPONADE OR EFFUSION AND GOOD LV FUNCTION. AFTER CONSIDERING HIS OPTIONS AND MUCH DISCUSSION WITH THE CRNA AND ANESTHESIOLOGIST, THE PHYSICIAN PERFORMED A SECOND TOUR OF THE HEART USING INTRACARDIAC ULTRASOUND AND SAW NO CHANGE IN COMPARISON TO THE HEART PRIOR TO THE TTE. AFTER MORE DISCUSSION, THE CRNA DREW BLOOD GAS SAMPLES AND WALKED THEM TO THE LAB WHILE LAB STAFF CHECKED A BLOOD SUGAR LEVEL THAT HAD A RESULT IN THE 400S. THE PATIENT'S COLOR WAS NOTED AS BEING 'ASHEY' DURING THIS TIME, ALONG WITH SOME DIAPHORESIS. THE PATIENT'S BLOOD PRESSURE ROSE AND SEEMED TO STABILIZE TO AROUND 100 SYSTOLIC. THE PHYSICIAN DECIDED TO ABANDON THE CASE. HE PULLED BACK THE TRANSSEPTAL SHEATHS FROM THE LEFT ATRIUM. HE WAITED FOR AN ACT RESULT, AND THEN THE RIGHT VENOUS SHEATHS WERE PULLED OUT OF THE BODY WHILE HOLDING PRESSURE. HOWEVER, IT WAS REPORTED LATER THAT THE PATIENT HAD CODED AND PASSED ON THE TABLE. DURING A FOLLOW-UP CONVERSATION WITH THE PHYSICIAN, HE STILL WASN'T SURE OF THE REASON FOR THE RESULT OF THE CASE AS NO EVIDENCE OF EFFUSION, TAMPONADE, OR ANY OBVIOUS TRAUMA HEART HAD BEEN NOTICED. THE PHYSICIAN'S OPINION REGARDING THE CAUSALITY OF THIS ADVERSE EVENT IS POSSIBLE PROCEDURE RELATED. NO AUTOPSY WAS PERFORMED AND IT WAS UNSURE IF ONE WAS PLANNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED DURING AN ABLATION PROCEDURE ON (B)(6) 2012. THE PATIENT WAS BROUGHT INTO THE LAB FOR A PAROXYSMAL ATRIAL FIBRILLATION ABLATION AND PREPPED FOLLOWING TYPICAL GUIDELINES. AFTER INDUCTION OF GENERAL ANESTHESIA, THE CRNA AND THE LAB STAFF NOTED THE HIGH BLOOD PRESSURE (SYSTOLIC OF 180S) AND HIGH HEART RATE (SINUS TACHYCARDIA IN 130S) OF THE PATIENT. THE STAFF HAD VERBALIZED THAT THE PATIENT WAS DIABETIC AND, ALSO, HAD AN EXTENSIVE MEDICAL HISTORY. THE PHYSICIAN OBTAINED VENOUS ACCESS IN BOTH GROINS. A 10F SOUNDSTAR INTRACARDIAC ULTRASOUND CATHETER WAS THEN INSERTED INTO THE RIGHT ATRIUM AND IMAGING OF THE LEFT ATRIUM AND SURROUNDING STRUCTURES WAS PERFORMED. DOUBLE TRANSSEPTAL ACCESS WAS GAINED, WHICH TOOK LONGER THAN NORMAL FOR THE PHYSICIAN. A FAM MAP OF THE LEFT ATRIUM AND THE SURROUNDING STRUCTURES WAS MADE TO GO ALONG WITH SOME CARTOSOUND MAPS THAT HAD BEEN BUILT BEFORE AND AFTER GOING TRANSSEPTAL. THE PHYSICIAN STARTING APPLYING RF LESIONS WITH A THERMOCOOL NAV BI-DIRECTIONAL F-J EZ STEER CATHETER ALONG THE RIGHT POSTERIOR WALL. THROUGH THIS POINT, THE CRNA AND THE PHYSICIAN HAD DISCUSSED THE VARYING HEMODYNAMICS OF THE PATIENT, WITH TALK OF THE FAST HR AND BLOOD PRESSURE THAT WOULD VARY BACK AND FORTH BETWEEN HYPERTENSION AND HYPOTENSION. WHILE ABLATING ALONG THE POSTERIOR WALL AND TOWARDS THE INFERIOR PORTION OF THE RIGHT INFERIOR PULMONARY VEIN OSTIUM, IT WAS BROUGHT TO THE PHYSICIAN'S ATTENTION THAT THE PATIENT HAD A RATHER LOW BLOOD PRESSURE. THE PHYSICIAN DECIDED TO PAUSE THE CASE AND USED THE INTRACARDIAC ULTRASOUND CATHETER TO CHECK FOR ANY SIGNS OF PERICARDIAL EFFUSION OR CARDIAC TAMPONADE, AS WELL AS ASSESSING LEFT VENTRICULAR FUNCTION. A TRACE EFFUSION WAS NOTED AROUND THE LEFT VENTRICLE. THE PHYSICIAN THEN HAD THE STAFF CALL FOR A TRANSTHORACIC ECHO.

    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-1292-04-S 15619765M

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death