BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12253629 · Received July 30, 2021

    Report

    Report Number
    2029046-2021-01221
    Event Type
    Death
    Date Received
    July 30, 2021
    Date of Event
    July 5, 2021
    Report Date
    July 7, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION DETAILS: THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A 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. BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: MANUFACTURE REPORT NUMBER # FOR PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER) . IMPORTER REPORT NUMBER # (B)(4) PRODUCT CODE M490007 (SMARTABLATE¿ SYSTEM RF GENERATOR (US)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT ( (B)(6)) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT SUFFERED ESOPHAGEAL FISTULA, POSSIBLE CEREBROVASCULAR ACCIDENT AND DEATH. IT WAS INITIALLY REPORTED THAT SEVERAL WEEKS AFTER AN ATRIAL FIBRILLATION CASE WAS COMPLETED, AN ESOPHAGEAL FISTULA WAS NOTICED IN THE PATIENT. THE CALLER REPORTED THAT THE PATIENT CAME INTO THE HOSPITAL EMERGENCY ROOM SOME DAY LAST WEEK (WEEK OF (B)(6)), BUT THE CALLER COULD NOT CONFIRM EXACTLY WHAT DAY. THE CALLER BELIEVES THAT THE PATIENT MAY HAVE BEEN UNRESPONSIVE OR EXHIBITING STROKE-LIKE SYMPTOMS WHEN THEY CAME INTO THE HOSPITAL, BUT THE CALLER WAS UNABLE TO CONFIRM THIS. THE CALLER REPORTED IT IS UNKNOWN HOW THE ESOPHAGEAL FISTULA WAS DISCOVERED. THE CALLER BELIEVES THE ESOPHAGEAL FISTULA MAY HAVE BEEN CONFIRMED VIA COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI) SCAN, BUT THE CALLER WAS UNABLE TO CONFIRM THIS INFORMATION. THE CALLER REPORTED THAT THE PHYSICIAN HAD ADVISED LAST WEEK THAT THE PATIENT WAS "NOT WAKING UP." THE CALLER DID NOT HAVE ANY INFORMATION REGARDING THE TYPE OF MEDICAL INTERVENTION PROVIDED TO THE PATIENT. THE CALLER WAS UNABLE TO CONFIRM WHAT CONDITION THE PATIENT IS CURRENTLY IN, OR IF THE PATIENT IS STABLE OR NOT AT THIS TIME. BIOSENSE WEBSTER INC. LATER RECEIVED ADDITIONAL INFORMATION INDICATING THE PATIENT IS DECEASED. DATE OF DEATH (B)(6) 2021. THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. IT WAS SIMPLY STATED THAT PATIENT WAS NOT A SURGICAL CANDIDATE DUE TO SIGNIFICANT NEUROLOGIC INJURY. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. CT ON BRAIN AND NECK WAS DONE ON (B)(6) 2021, CT ON CHEST AND HEART DONE ON (B)(6) 2021. PAST MEDICAL HISTORY INCLUDED HYPERTENSION, OBSTRUCTIVE SLEEP APNEA, OBESITY. ADDITIONAL DETAILS ABOUT THE ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WHICH OCCURRED ON (B)(6) 2021 WERE ALSO RECEIVED FROM THE BIOSENSE WEBSTER INC. REPRESENTATIVE WHO WAS PRESENT DURING THE PROCEDURE. IT WAS REPORTED THE ABLATION WAS FOR ATRIAL FIBRILLATION USING A PULMONARY VEIN ISOLATION (PVI) AND POSTERIOR WALL BOX ISOLATION. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. TEMPERATURE PROBE AND ESOPHAGEAL DEVIATION DEVICE WAS USED. THERE WAS NO RECOLLECTION OF TEMPERATURE RISE DURING THE CASE. THE SMARTABLATE GENERATOR DID RECEIVE SERVICING IN MAY OF 2021, PRIOR TO THE CASE. PATIENT RETURNED THE WEEK OF (B)(6) AND CT SCAN DID CONFIRM THE FINDING OF ESOPHAGEAL FISTULA. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT HE BELIEVES IT WAS A PROCEDURAL COMPLICATION. THE PHYSICIAN REPORTS THAT THE EVENT IS RELATED TO PROCEDURE BUT NOT SPECIFICALLY TO BWI PRODUCT. THE PHYSICIAN¿S OPINION IS THAT PATIENT DIED FROM COMPLICATIONS (AIR EMBOLI) RELATED TO THE ESOPHAGEAL FISTULA. THE PHYSICIAN JUST SIMPLY STATED PATIENT DEVELOPED FISTULA OVER TIME AFTER CASE THAT RESULTED IN AIR EMBOLI OCCURRING THAT CAUSED A STROKE THAT EVENTUALLY LED TO PATIENT¿S DEATH. DURING THE ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE, THE SMARTABLATE GENERATOR WAS SET TO POWER CONTROL MODE, WITH TIMER AT 60SEC., 40W (50W ANTERIOR), TEMP. ¿ 37 WARNING, 40 CUT OFF, ABLATION ¿ 250 MAX IMPEDANCE, 50 OHMS/.5SEC. SPIKE CUT OFF, 50 OHMS MIN. CUT OFF. CIRCA TEMPERATURE PROBE AND ESOSURE ESOPHAGEAL DEVIATION DEVICE WAS USED TO PREVENT ESOPHAGEAL INJURY. NO PERFORATION OCCURRED. THE CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. FORCE VISUALIZATION FEATURES USED: DASHBOARD, GRAPH TAKEN FROM CT, VECTOR, VISITAG WITH THE VISITAG MODULE PARAMETERS FOR STABILITY: VISITAG SETTINGS ¿ 3MM, 3-4 SEC., 25% FOT, 3G FORCE AND RESPIRATORY ADJUSTMENT. COLOR OPTIONS PROSPECTIVELY: VISITAGS COLORED BY IMPEDENCE DROP OF 5-10OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151137 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| H| R CARTO 3 SYSTEM| CIRCA TEMPERATURE PROBE| ESOSURE ESOPHAGEAL DEVIATION| SMARTABLATE GENERATOR KIT-US