BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 12784763 · Received November 10, 2021

    Report

    Report Number
    2029046-2021-01927
    Event Type
    Death
    Date Received
    November 10, 2021
    Date of Event
    January 1, 2021
    Report Date
    January 6, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835008982
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 6-JAN-2022, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30566933M NUMBER, AND NO NON-CONFORMANCES RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT (B)(6) MALE PATIENT UNDERWENT A PREMATURE VENTRICLE CONTRACTION(PVC) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE AND DEATH. THE PATIENT DIED AS A RESULT OF PERICARDIAL TAMPONADE THAT OCCURRED DURING A MAPPING PROCEDURE WITH CARTO 3 TECHNOLOGY. IT WAS A PREMATURE VENTRICLE CONTRACTION (PVC) PROCEDURE, THE PVC CAME FROM LEFT VENTRICLE (LV). FIRST THE OPERATING TEAM MAPPED ALL CHAMBERS WITH THE SOUNDSTAR CATHETER (ICE) POSITIONED IN THE RIGHT ATRIUM (RA) AND SOMETIME ALSO IN THE RIGHT VENTRICLE (RV). AFTER THAT, WE MAPPED THE PVC FROM CORONARY SINUS (CS) WITH THE THERMOCOOL ST(ST) INSERTED INSIDE AN NXT AGILIS. THE OPERATING TEAM WAS TOLD TO ZERO OF THE FORCE TO CALIBRATE THE SENSOR BEFORE TO INSERT THE ABLATION CATHETER INSIDE THE CS BUT THEY DIDN'T. THEN IT WAS CONFIRMED THAT THE PVC CAME FROM LV. THEY POSITIONED AN INQUIRY CATHETER (ABBOTT) INSIDE THE AGILIS SHEATH AFTER REMOVING THE ABLATION CATHETER FROM CS. THE MEDICAL STAFF ENTERED IN LV WITH TRANSAORTIC APPROACH JUST WITH THE ABLATION CATHETER, WE MAPPED AND ABLATED THE FOCUS OF THE PVC AT 2 O'CLOCK OF THE MITRAL VALVE (MV). THEY MADE THE ZERO OF CONTACT FORCE BEFORE TO MAP AND ABLATE (I SET UP A CONTACT RANGE FROM 3 TO 30 G AND A RED ALERT ABOVE 40 G). WE MADE 4 OR 5 ABLATIONS WITH 40-50 W, WITH A MAXIMUM AVERAGE OF CONTACT FORCE (CF ) OF 25 G. NO SHARP IMPEDANCE DROP DURING ABLATIONS (A CUT OFF OF 30 OHM WAS APPLIED BEFORE TO START THE ABLATION PHASE). MAXIMUM DELTA IMPEDANCE WAS 22 OHM. THE LONGEST ABLATIONS LASTED ABOUT 90 SEC. DURING ONE ABLATION THE GENERATORS INDICATED A TEMPERATURE OF ABOUT 41°C WITHOUT REACHING THE CUT OFF TEMPERATURE THRESHOLD(USUALLY 44-45°C). THE PHYSICIAN WAS INFORMED OF THIS BUT THEY DIDN'T WANT TO STOP THE ABLATION. ONE MINUTE LATER THE ABLATION PHASE, THE ABLATION CATHETER WAS AT THE AORTIC ARCH LEVEL AND THE MEDICAL STAFF DETECTED A PERICARDIAL TAMPONADE THANKS TO VIVID I INTRACARDIAC ECO IMAGES. SO THEY STARTED TO HANDLE THE PRIMARY ADVERSE EVENT. AT THE BEGINNING THE PERICARDIAL TAMPONED SEEMED TO RECOVER AFTER PERICARDIOCENTESIS, BUT AFTER SOMEWHILE THE COMPLICATION CAME BACK. THEY STARTED TO USE THE ANGIOGRAPHY EXAM WITH CONTRAST TO LOOK FOR THE LOSS IN ALL CHAMBERS (CS, RV, PULMONARY ARTERY, CORONAROGRAPHY, AORTA, LV) BUT IT WAS NOT SO OBVIOUS WHERE IT COULD BE. AT THE END THEY FOUND SOMETHING BARELY PERCEPTIBLE IN CORRESPONDENCE WITH ABLATIONS MADE. FORCE VISUALIZATION DASHBOARD, VECTOR AND VISITAG ON THE SECONDARY MONITOR: GRAPH, POSITION STABILITY 3 MM, LAT 3MS, 6. FORCE OVERTIME%:25%, FORCE 3 G, 7. TAG INDEX. THE EVENT OCCURRED ON (B)(6) 2021. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: PROCEDURE. INTERVENTION: PERICARDIOCENTESIS, ANGIOGRAPHY EXAMS WITH CONTRAST. RELEVANT HISTORY: POSSIBLE LOOP RECORDER IMPLANTED. GENERATOR USED SMART ABLATE. A TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. PRIOR TO NOTING THE CT ABLATION WAS PERFORMED. NO STEAM POP. THE EVENT OCCURRED: PROBABLY AT THE END OF ABLATION PHASE, BUT WE CANNOT SAY IT EXACTLY. THERMOCOOL ST D CURVE SETTING 2ML/MIN FOR MAPPING PHASE 30 ML/MIN FOR ABLATION PHASE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THE PUMP SWITCHING FROM ¿LOW TO HIGH FLOW DURING ABLATION. A BUBBLE ERROR OCCURRED AT THE VERY BEGINNING OF ABLATION, BUT THE MEDICAL STAFF WERE UNABLE TO FIND BUBBLES IN THE TUBE THEREFORE THEY BELIEVED THAT THE ISSUE WAS DUE TO THE SHIFT OF THE TUBE BEHIND THE SMART PUMP SENSOR--IN FACT ONCE THAT THEY POSITIONED THE TUBE CORRECTLY, NO MORE BUBBLE ERROR OCCURRED. ALL DEATHS WHERE BWI FDA APPROVED ¿ CE MARK DEVICES ARE INVOLVED ARE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686363 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D133601 30566933M 10846835008982

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R| D ABBOTT INQUIRY CATHETER.| AGILIS SHEATH.| CARTO 3 SYSTEM.| SMARTABLATE GENERATOR.| SOUNDSTAR ECO CATHETER.| VISITAG MODULE.