BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSPAN TRANSSEPTAL NEEDLE & STYLET KIT

    MDR report key: 2850957 · Received November 19, 2012

    Report

    Report Number
    2529252-2012-00008
    Event Type
    Death
    Date Received
    November 19, 2012
    Date of Event
    August 16, 2012
    Report Date
    October 26, 2012
    Manufacturer
    THOMAS MEDICAL PRODUCTS
    Product Code
    DRC
    PMA / PMN Number
    K011727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE INITIALLY PROVIDED THE EVENT INFORMATION TO BIOSENSE WEBSTER, INC. (BWI) ON (B)(6) 2012. BWI NOTIFIED GE HEALTHCARE ON (B)(4) 2012. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THE PROPER MATERIALS AND MANUFACTURING METHODS WERE USED TO PRODUCE THIS LOT OF NEEDLES. COMPLAINT SAMPLE WAS DISCARDED AT THE USER FACILITY. INFORMATION PROVIDED BY BWI INDICATES THAT THE NEEDLE WAS USED AS INTENDED AND THERE WAS NO MALFUNCTION ON THE PART OF THE TRANSSEPTAL NEEDLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A HEARTSPAN TRANSSEPTAL NEEDLE WAS USED DURING A PROCEDURE TO TREAT ATRIAL FIBRILLATION. AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT DIED. PHYSICIAN'S NAME AND PHONE NUMBER OR EMAIL ADDRESS: (B)(6). SEQUENCE OF EVENTS LEADING UP TO PATIENT'S DEATH - 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 THE HIGH HEART RATE (SINUS TACHYCARDIA IN 130'S) OF THE PATIENT. THE STAFF HAD VERBALIZED THAT THE PATIENT WAS DIABETIC AND, ALSO, HAD AN EXTENSIVE MEDICAL HISTORY. DR. (B)(6) 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 DR. (B)(6). 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. DR (B)(6) 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 DR (B)(6) 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 DR (B)(6) ATTENTION THAT THE PATIENT HAD A RATHER LOW BLOOD PRESSURE. DR (B)(6) 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. DURING THIS TIME, I WAS ABLE TO BUILD A CARTOSOUND CONTOUR TO KEEP A CLIP OF THE EFFUSION STORED ON C3 IN CASE DR (B)(6) NEEDED TO REFERENCE THAT IMAGE LATER FOR COMPARISON. DR (B)(6) THEN HAD THE STAFF CALL FOR A TRANSTHORACIC ECHO. THE ECHO TECHNICIAN ARRIVED AND PERFORMED A TRANSTHORACIC ECHO WHILE DR (B)(6) WAS WATCHING INTENTLY. 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, DR (B)(6) 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 400'S. THE PATIENT'S COLOR WAS NOTED AS BEING "ASHY" BY DR. (B)(6) AND THE ANESTHESIOLOGIST DURING THIS TIME, ALONG WITH SOME DIAPHORESIS. THE PATIENT'S BLOOD PRESSURE ROSE AND SEEMED TO STABILIZE TO AROUND 100 SYSTOLIC. DR (B)(6) 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. DR (B)(6) THEN LEFT THE LAB TO TALK TO THE FAMILY MEMBERS IN THE WAITING ROOM. DURING THIS TIME, I ASSISTED IN GETTING THE LOCATION PAD REMOVED FROM THE BRACKET UNDER THE TABLE WHILE THE STAFF REMOVED THE PATIENT CABLES FROM THE PATCHES. AFTER A LITTLE WAITING TO MAKE SURE EVERYTHING WAS OK, I CONFIRMED THAT THERE WAS NOTHING ELSE I COULD DO TO ASSIST THE STAFF AND LEFT THE LAB. I WENT TO LUNCH AND WAITED FOR THE PHONE CALL TO LET ME KNOW WHEN THE FOLLOWING PATIENT WAS READY FOR ME TO COME BACK INTO THE LAB. AFTER APPROXIMATELY 1.5 HOURS, A LAB STAFF MEMBER CALLED TO TELL ME THAT THE SECOND CASE WAS RESCHEDULED BECAUSE THE PATIENT HAD CODED AND PASSED ON THE TABLE FOLLOWING MY DEPARTURE. DURING A FOLLOW-UP CONVERSATION WITH DR (B)(6), 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSPAN TRANSSEPTAL NEEDLE & STYLET KIT TRANSSEPTAL NEEDLE & STYLET KIT DRC THOMAS MEDICAL PRODUCTS FND-020-02 S38817

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death THERMOCOOL FJ BI-DIRECTIONAL CATHETER MANUFACTURED| BIOSENSE WEBSTER, INC.| WEBSTER, INC.| SOUNDSTAR CATHETER, MANUFACTURED BY BIOSENSE| CARTO 3 EP NAVIGATION SYSTEM MANUFACTURED BY| EZ STEER BI-DIRECTIONAL CATHETER, MANUFACTURED BY| BY BIOSENSE WEBSTER, INC| BIOSENSE WEBSTER, INC.