BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12363913 · Received August 25, 2021

    Report

    Report Number
    2029046-2021-01386
    Event Type
    Death
    Date Received
    August 25, 2021
    Date of Event
    July 28, 2021
    Report Date
    July 28, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009774
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 25-AUG-2021 AND IT WAS REPORTED THAT THE DATE OF DEATH WAS (B)(6) 2021. THEREFORE, B2. DATE OF DEATH HAS BEEN UPDATED. THE EVENT DATE WAS REPORTED AS (B)(6) 2021. THEREFORE, B 3. DATE OF EVENT WAS UPDATED. IN THE PHYSICIAN¿S OPINION, THE CAUSE OF DEATH WAS THAT AFTER ELECTRICAL CARDIOVERSION OF THE PATIENT DURING PULMONARY VEIN ISOLATION (PVI), THE PATIENT BECAME CYANOTIC. THE PATIENT WAS IN GOOD CONDITION BEFORE THE EXAMINATION. DUE TO CYANOSIS OR HYPOXIA, THE PATIENTS¿ DEATH WAS CAUSED BY CEREBRAL DEATH. IT WAS CONFIRMED THAT A THERMOCOOL®SMARTTOUCH® SF WAS USED. FORCE VISUALIZATION FEATURES USED WERE: GRAPH, DASHBOARD, VECTOR AND VISITAG WITH THE VISITAG MODULE PARAMETERS FOR STABILITY SET AT: MAXIMUM DISTANCE CHANGE OF 3MM AND MINIMUM TIME OF 3S. ADDITIONAL FILTER USED WITH THE VISITAG WAS RESPIRATION ADJUSTMENT. FORCE OVER TIME: 25%, MINIMUM FORCE: 3G, TAG INDEX (ANTERIOR): LOW: 400; HIGH: 550 & TAG INDEX (POSTERIOR): LOW: 300; HIGH 400. PER INTERNAL REVIEW BY BIOSENSE WEBSTER INC.'S MEDICAL SAFETY OFFICER ON (B)(6) 2021, AFTER CARDIOVERSION TO SINUS RHYTHM, THE PATIENT EXPERIENCED SIGNIFICANT BRADYCARDIA. EVENTUALLY, THIS LED TO HYPOXEMIA SUGGESTING THAT CARDIAC OUTPUT WAS NOT ADEQUATE. CHECK FOR PERICARDIAL EFFUSIONS DID NOT REVEAL ONE AND EVENTUALLY HEART BLOCK RESULTED, LIKELY AS A RESULT OF THE HYPOXEMIA AND ACIDOSIS THAT OCCURRED WITH REDUCED CARDIAC OUTPUT. THIS MAY HAVE BEEN THE RESULT OF ELECTROMECHANICAL DISSOCIATION. THERE IS NO MENTION OF PRODUCT MALFUNCTION DURING THE CASE. PATIENT ARRESTED AND DUE TO PROLONGED CEREBRAL ISCHEMIA, THE EVENTS RESULTED IN AN OUTCOME OF DEATH. 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 · 1

    DATE OF EVENT: THE EVENT YEAR REPORTED IS 2021. INITIAL REPORTER PHONE: (B)(6). THE OTHER SURGEON'S CONTACT INFORMATION: (B)(6). THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER (STSF) AND SUFFERED A HEART BLOCK REQUIRING TEMPORARY PACEMAKER IMPLANTATION. THE PATIENT ALSO EXPERIENCED HYPOXIA AND THE VENTRICLES STOPPED BEATING (CARDIAC ARREST) LEADING TO DEATH. THE PROCEDURE STARTED WITH THE PATIENT IN PERSISTENT ATRIAL FIBRILLATION. THE OBJECTIVE OF THE PROCEDURE WAS THE ISOLATION OF THE PULMONARY VEINS USING CARTO MAPPING SYSTEM AND RF-TECHNOLOGY. THE PHYSICIAN USED A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER, LASSO® NAV ECO VARIABLE CATHETER, AND A MOBICATH SMC GUIDING SHEATH , AS WELL AS A 10-POL CORONARY SINUS CATHETER (ABBOTT). AFTER MAPPING IN ATRIAL FIBRILLATION AND PROPER ISOLATION OF THE RIGHT PULMONARY VEINS, THE PHYSICIAN DECIDED FOR CARDIOVERSION IN ORDER TO VALIDATE THE ISOLATION OF THE RIGHT PULMONARY VEINS IN SINUS RHYTHM. AFTER CARDIOVERSION, THE PATIENT WAS IN BRADYCARDIA WITH A HEART RATE OF APPROXIMATELY 40 BPM. THE PHYSICIAN STARTED ATRIAL STIMULATION OVER CS 5-6 WITH AN INITIAL FREQUENCY OF 800MS, AND DECREASED THE FREQUENCY TO 1000MS, AND FINALLY TO 1500MS TO CHECK THE HEARTS NATURAL RHYTHM. AT THAT TIME, THE PATIENT HAD A SUFFICIENT HEART RHYTHM. HOWEVER, THE PHYSICIAN NOTICED THAT THE PATIENT'S OXYGEN SATURATION DECREASED AND STARTED VENTILATION. IN THE MEANTIME, THE OTHER PHYSICIAN STARTED AN ECHOCARDIOGRAPHY TO CHECK FOR PERICARDIAL EFFUSION. ACCORDING TO THE PHYSICIAN, NO PERICARDIAL EFFUSION COULD BE OBSERVED. AFTER A FEW SECONDS, AN AV BLOCK III OCCURRED SPONTANEOUSLY, AND THE PATIENT¿S VENTRICLES STOPPED BEATING. AT THIS POINT, THE PROCEDURE WAS STOPPED AND THE PHYSICIANS STARTED REANIMATION OF THE PATIENT. THE PHYSICIANS DECIDED TO IMPLANT A TEMPORARY PACEMAKER FOR CARDIAC STABILIZATION. AFTER IMPLANTATION, THE PATIENT WAS STABLE AND WAS TAKEN TO THE INTENSIVE CARE UNIT. AT THAT TIME, THE PATIENT WAS HEMODYNAMICALLY STABLE. ACCORDING TO THE PHYSICIAN, THIS ADVERSE EVENT IS NOT DIRECTLY LINKED TO THE CARTO AND OTHER BIOSENSE WEBSTER INC. PRODUCTS. THE PHYSICIAN USED THE PROPER SETTINGS ON THE SA GENERATOR FOR THE STSF CATHETER AND USED MAX. 30W ON THE POSTERIOR WALL AND MAX. 35 WATTS ANTERIOR. NO ERRORS OR HARMFUL EVENTS WERE OBSERVED DURING MAPPING OR ABLATION. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. DUE TO INTRAOPERATIVE COMPLICATIONS THE PROCEDURE WAS STOPPED. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS REPORTED THAT THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: ¿ NO MALFUNCTION, NO PROCEDURAL FAILURE OR RELATED TO PATIENT CONDITION.¿ THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF INTENSIVE CARE, VENTILATION OF PATIENT BEFORE DEATH. PATIENT HAD A HISTORY OF ATRIAL FIBRILLATION. THERE WERE NO ALLEGATIONS AGAINST THE MOBICATH SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262317 THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134701 10846835009774

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| L| R ABBOTT 10-POL CORONARY SINUS CATHETER| LASSO NAV 2515,22P SPLITHANDLE| MOBICATH SMC GUIDING SHEATH| UNK_CARTO 3| ABBOTT 10-POL CORONARY SINUS CATHETER| LASSO NAV 2515,22P SPLITHANDLE| MOBICATH SMC GUIDING SHEATH| UNK_CARTO 3