SmartAblateTM System RF Generator M490007Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 04260166371390), received between Dec 1, 2017 and Dec 31, 2024 — classified as 20 deaths, 40 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (23 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2024Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  IT WAS REPORTED BY THE CALLER, CLINICAL ACCOUNT SPECIALIST, THAT THE PHYSICIAN INFORMED THE CLINICAL ACCOUNT SPECIALIST TODAY THAT THE PATIENT HAD A STROKE POST ATRIAL FIBRILLATION ABLATION PROCEDURE. THE CALLER STATED THAT DURING THE PROCEDURE THE HEALTH CARE PROFESSIONAL STAFF MEMBER SET THE SETTINGS ON THE SMARTABLATE GENERATOR INCORRECTLY TO A 4MM CATHETER. THE CALLER STATED THAT THERE WAS CHAR ON THE CATHETER TIP AND THERE WERE 4 STEAM POPS DURING THE PROCEDURE. THE CALLER STATED THAT ABOUT HALFWAY THROUGH THE PROCEDURE IT WAS NOTED THAT THE SETTINGS ON THE SMARTABLATE GENERATOR WERE SET INCORRECTLY. THE CALLER STATED THAT THERE WAS NO INDICATION IMMEDIATELY POST PROCEDURE THAT THE PATIENT HAD SUFFERED FROM A STROKE. THE CALLER STATED THAT THE PATIENT WAS STABLE DURING THE PROCEDURE AND WHEN THEY LEFT THE LAB. THE CALLER ALSO STATED THAT THE EP PHYSICIAN REQUESTED A NEURO TEAM CONSULT IMMEDIATELY POST PROCEDURE AS A PREVENTATIVE MEASURE, BEFORE THE PATIENT LEFT THE EP LAB. THE CALLER STATED THAT THE NEURO PHYSICIAN ADVISED THE EP PHYSICIAN TO MONITOR THE PATIENT FOR ANY STROKE LIKE SIGNS OR SYMPTOMS, AT THAT TIME. THE CALLER STATED THAT THE PATIENT LOST PART OF THEIR VISION, W

  Patient problems: Stroke/CVA

  MAUDE report 21050469 ↗
• InjuryApr 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT EXPERIENCED A SKIN BURN. THE ADVERSE EVENT OCCURRED ON 03-OCT-2023. THE PHYSICIAN WAS UNSURE WHAT CAUSED THE EVENT BUT SUSPECTED IT COULD BE AN ISSUE WITH THE INDIFFERENT ELECTRODE. ACCORDING TO THE PHYSICIAN, NO INTERVENTION WAS PROVIDED. THE PHYSICIAN STATED THAT HEALING HAD ALREADY BEGUN BY THE TIME THE INJURY WAS OBSERVED, SCAR REMAINS. ACCORDING TO THE PHYSICIAN, THE PATIENT'S INJURY STATUS HAS IMPROVED. THE INDIFFERENT ELECTRODE USED FOR THE PROCEDURE IS CALLED VALLEYLAB REM POLYHESIVE ADULT PATIENT RETURN ELECTRODE. THE PRODUCT IS MADE BY COVIDIEN. THE SERIAL AND LOT NUMBER OF THE PRODUCT USED IN THE PROCEDURE IS UNKNOWN. THE PATIENT CONTACT AREA AND INDIFFERENT ELECTRODE WERE PROPERLY PREPARED. THE INDIFFERENT ELECTRODE WAS PLACED ON THE PATIENTS LOWER BACK, JUST BELOW THE BACK PATCHES. THE INDIFFERENT ELECTRODE WAS POSITIONED AS CLOSE TO THE PATIENT¿S HEART AS POSSIBLE. IT WAS BELIEVED THAT THERE WERE NO AIR POCKETS BETWEEN THE SKIN AND THE INDIFFERENT ELECTRODE AND THAT THE ENTIRE SURFACE AREA OF THE PRODUCT WAS IN CONTACT WITH THE PATIENT¿S SKIN. THERE

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19133936 ↗
• InjuryApr 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SMARTABLATE¿ SYSTEM RF GENERATOR (AND THE PATIENT EXPERIENCED 3RD DEGREE BURN. THE PATIENT HAD A BURN THAT WAS NOT OBSERVED DIRECTLY AFTER THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PATIENT SUFFERED A 3RD DEGREE BURN. THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE INJURY. NO INTERVENTION WAS PROVIDED. THE PHYSICIAN STATED THAT HEALING HAD ALREADY BEGUN BY THE TIME THE INJURY WAS OBSERVED. THE PATIENT'S CONTACT AREA AND INDIFFERENT ELECTRODE WERE PROPERLY PREPARED. THE INDIFFERENT ELECTRODE WAS PLACED ON THE LOWER BACK, JUST BELOW THE PATIENT¿S BACK PATCHES. THE INDIFFERENT ELECTRODE USED FOR THE PROCEDURE IS CALLED VALLEYLAB REM POLYHESIVE ADULT PATIENT RETURN ELECTRODE. THE PRODUCT IS MADE BY COVIDIEN. THE INDIFFERENT ELECTRODE WAS POSITIONED ON THE PATIENT¿S BACK AS CLOSE TO THE PATIENT¿S HEART AS POSSIBLE. THERE WERE NO AIR POCKETS BETWEEN THE SKIN AND THE INDIFFERENT ELECTRODE AND THAT THE ENTIRE SURFACE AREA OF THE PRODUCT WAS IN CONTACT WITH THE PATIENT¿S SKIN. THERE WAS NO CONDUCTIVE GEL PRESENT ON THE INDIFFERENT ELECTRODE. ACCORDING TO LAB STAFF, NO CONDUCTIVE GEL IS TYPICALLY USED. THE I

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19120605 ↗
• DeathMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION, AND THE PATIENT EXPERIENCED AN ESOPHAGEAL FISTULA THAT RESULTED IN DEATH. IT WAS REPORTED THAT AN ESOPHAGEAL FISTULA WAS RECEIVED FROM AN EMERGENCY ROOM (ER) PHYSICIAN ON A PATIENT WHO HAD GONE THROUGH AN AFIB PROCEDURE ON (B)(6) 2024. THE PHYSICIAN STATED THAT THE PATIENT CAME TO THE ER ON THAT DATE COMPLAINING OF CHEST DISCOMFORT. THE PATIENT WAS SENT FOR A COMPUTED TOMOGRAPHY (CT) SCAN TO EVALUATE THE ISSUE AND PASSED AWAY WHILE HAVING THE CT SCAN DONE. THERE WAS NO INFORMATION REGARDING THE ABLATION OR DIAGNOSTIC CATHETERS NOR HAS THE INFORMATION FOR THE GENERATOR USED FOR ABLATION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LOT NUMBERS OF THE DEVICES ARE UNKNOWN AS THE EVENT DID NOT OCCUR UNTIL WEEKS AFTER THE ABLATION. THEREFORE, ALL CATHETERS AND CABLES HAD BEEN SENT TO REPROCESSING. CONFIRMATION WAS RECEIVED THAT A SMARTABLATE GENERATOR WAS USED AND THE SERIAL NUMBER WAS PROVIDED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF DEATH WAS ATRIO-ESOPHAGEAL (AE) FISTULA. IT IS UNKNOWN WHEN IN THE PROCEDURE THE FISTULA OCCURRED AS THE PHYSICIAN AND STAFF WERE VERY DILIGENT AND CONSERVATIVE

  Patient problems: Fistula

  MAUDE report 18877249 ↗
• InjuryDec 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SMARTABLATE¿ SYSTEM RF GENERATOR, AND EXPERIENCED AN ESOPHAGEAL FISTULA AND RECEIVED A SURGICAL INTERVENTION. THE ONLY INFORMATION PROVIDED WAS THAT THE PATIENT SUFFERED AN ESOPHAGEAL FISTULA AFTER THE PROCEDURE BUT COULD NOT CONFIRM WHEN IT HAPPENED AND ANY DETAILS ON HOW THE INJURY WAS DISCOVERED. PATIENT HAS IMPROVED. THE CATHETER WORKED AS EXPECTED WITH NO ISSUES DURING THE PROCEDURE. CORRECT SETTINGS WERE UTILIZED ON DEVICES AND NO ERRORS MESSAGES ON THE EQUIPMENT. AN ESOPHAGEAL TEMPERATURE MONITORING SINGLE PROBE WAS USED TO PREVENT ESOPHAGEAL INJURY. THE PHYSICIAN'S OPINION ON THE CAUSE WAS THAT IT WAS PROCEDURE RELATED.

  Patient problems: Fistula

  MAUDE report 18292776 ↗
• InjuryDec 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SMARTABLATE¿ SYSTEM RF GENERATOR, AND EXPERIENCED AN ESOPHAGEAL FISTULA AND RECEIVED INTERVENTION; HOWEVER, DETAILS ARE UNKNOWN. THE ONLY INFORMATION PROVIDED WAS THAT THE PATIENT SUFFERED AN ESOPHAGEAL FISTULA AFTER THE PROCEDURE BUT COULD NOT CONFIRM WHEN IT HAPPENED AND ANY DETAILS ON HOW THE INJURY WAS DISCOVERED. THE LAST KNOWN STATUS OF THE PATIENT WAS STABLE. NO OTHER DETAILS OR INFORMATION WERE PROVIDED. THE CATHETER WORKED AS EXPECTED WITH NO ISSUES DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED. THE ADVERSE EVENT OCCURRED AFTER THE PROCEDURE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. PATIENT HAS IMPROVED.

  Patient problems: Fistula

  MAUDE report 18292611 ↗
• DeathNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE USING A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA AND THE PATIENT ULTIMATELY PASSED AWAY. A PATIENT EXPIRED POST-ATRIAL FIBRILLATION ABLATION PROCEDURE WHICH WAS PERFORMED ON (B)(6) 2021, AFTER WHICH THEY DEVELOPED AN ESOPHAGEAL FISTULA (BELIEVED TO BE THE CAUSE OF DEATH). NO FURTHER DETAILS ABOUT WHEN OR HOW THE FISTULA WAS DIAGNOSED, OR THE DATE THE PATIENT EXPIRED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Fistula

  MAUDE report 18166338 ↗
• InjurySep 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE THAT INCLUDED THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SMARTABLATE¿ SYSTEM RF GENERATOR (US). THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA THAT REQUIRED SURGICAL INTERVENTION. PATIENT WAS TREATED ON (B)(6) 2023 AND WAS IN SURGERY (B)(6) 2023 FOR AN ESOPHAGEAL FISTULA THAT WAS FOUND. THE PATIENT WAS IN STABLE CONDITION AT THAT TIME. THE GENERATOR HAD BEEN USED FOR SEVERAL OTHER SUCCESSFUL PROCEDURES SINCE THE CASE ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. PATIENT REQUIRED EXTENDED HOSPITALIZATION, THEY WERE READMITTED FOR THIS AS IT WAS APPROXIMATELY TWO WEEKS POST PROCEDURE. ACCOUNT IS NOT REQUESTING SERVICE OF THE GENERATOR AT THIS TIME (GENERATOR HAS BEEN USED FOR DOZENS OF CASES SINCE). THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SMARTABLATE¿ SYSTEM RF GENERATOR (US).

  Patient problems: Fistula

  MAUDE report 17751061 ↗
• DeathSep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AF) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION REQUIRING CORONARY STENTING, CARDIAC TAMPONADE, CARDIAC ARREST AND ESOPHAGEAL FISTULA AND DEATH. A FEW DAYS AFTER AN AFIB CASE, THERE WAS A PATIENT DEATH. THE PATIENT WENT INTO THE HOSPITAL HAVING WHAT WAS SUSPECTED TO BE A HEART ATTACK, THEY STENTED HIS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE PATIENT WENT INTO CARDIAC ARREST. THEY DID A PERICARDIOCENTESIS AND AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. THIS WAS ALL REPORTED BY THE HOSPITAL STAFF WHICH HAD ¿HEARD¿ OF WHAT HAPPENED BUT WERE NOT PRESENT DURING THE EVENT. THE PHYSICIAN LATER STATED THE CAUSE OF DEATH WAS RELATED TO AN ATRIAL ESOPHAGEAL FISTULA CAUSED BY AN AF ABLATION PROCEDURE. HE STATED THIS IS A PROCEDURAL COMPLICATION BUT NO AUTOPSY WAS PERFORMED ON THE PATIENT.

  Patient problems: Fistula

  MAUDE report 17712767 ↗
• DeathAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US). THE PATIENT DEVELOPED AN ESOPHAGEAL FISTULA AND ULTIMATELY PASSED AWAY. CALLER REPORTED THAT THEY WERE NOTIFIED ON (B)(6) 2023, THAT A PATIENT WHO HAD AN ATRIAL FIBRILLATION ABLATION PROCEDURE PERFORMED ON (B)(6) 2023, DIED ON AN UNKNOWN DATE, EITHER (B)(6) 2023 OR (B)(6) 2023, DUE TO A SUSPECTED ESOPHAGEAL FISTULA. THE CALLER STATED THAT THE PHYSICIAN STATED THAT THE PATIENT COMPLAINED ABOUT GERD OR HEARD BURN AND THAT IS WHY THEY THINK IT COULD BE AN ESOPHAGEAL FISTULA. THE CALLER ALSO STATED THAT THERE WAS NOTHING THEY CAN THINK OF DURING THE PROCEDURE. THE CALLER DOES NOT HAVE ANY ADDITIONAL INFORMATION REGARDING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. THE ADVERSE EVENT OCCURRED ON (B)(6) 2023. IT WAS DISCOVERED POST USE (ABLATION WAS ON (B)(6) 2023. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PROCEDURE. OUTCOME OF THE ADVERSE EVENT WAS DEATH. VISITAG MODULE WAS USED, PARAMETERS FOR STABILITY USED WAS 3MM, 3SECONDS. ADDITIONAL FILTER USED WITH T

  Patient problems: Fistula

  MAUDE report 17600444 ↗
• InjuryAug 11, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ATRIAL FIBRILLATION ABLATION PROCEDURE THAT INCLUDED THERMOCOOL SMARTTOUCH SF CATHETER. THE PATIENT EXPERIENCED AN ESOPHAGEAL FISTULA THAT REQUIRED SURGICAL INTERVENTION. TIMING OF ADVERSE EVENT: POST USE OF BWI PRODUCTS, APPROXIMATELY 2 DAYS AFTER THE PROCEDURE. DESCRIPTION OF HEALTH HAZARD: IT WAS REPORTED THAT THE PATIENT HAD AN ADVERSE EVENT POST-PROCEDURE LAST MONTH. THE PATIENT SUFFERED AN ESOPHAGEAL- PERICARDIAL FISTULA, APPROXIMATELY 2 DAYS AFTER THE PROCEDURE. THE PHYSICIAN SAID THAT IT WAS POSSIBLY A PERFORATION FROM THE TEMPERATURE PROBE IN USE, BUT CANNOT BE SURE. THERE WAS AIR GETTING TRAPPED IN THE PERICARDIUM, CAUSING DISCOMFORT FOR THE PATIENT TWO DAYS AFTER THE PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL (EARLY JULY), THEN TRANSFERRED TO ANOTHER HOSPITAL AT SOME POINT, WHERE AN ESOPHAGEAL STENT WAS PLACED. THE PATIENT HAD A PRIOR BREAST CANCER DIAGNOSIS WITH SIGNIFICANT RADIATION. THE PHYSICIAN STATED THAT THE PATIENT MAY BE DISCHARGED TODAY. PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT: MAY BE DUE TO A PERFORATION OF THE ESOPHAGUS THAT POSSIBLY COULD HAVE HAPPENED FROM THE TEMPERATURE PROBE IN USE, BUT REAL

  Patient problems: Fistula

  MAUDE report 17511986 ↗
• InjuryMay 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AFIB - PAROXYSMAL ABLATION PROCEDURE WITH AN THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT DEVELOPED AN ESOPHAGEAL FISTULA POST-PROCEDURE REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT AN ESOPHAGEAL FISTULA OCCURRED POST-PROCEDURE. THEY REPORTED THAT THE PROCEDURE OCCURRED ON (B)(6) 2023 BUT THEY WERE UNABLE TO CONFIRM THE DATE THAT THE ESOPHAGEAL FISTULA WAS DISCOVERED. THE CALLER REPORTED THAT THEY WERE NOTIFIED OF THE ESOPHAGEAL FISTULA ON (B)(6) 2023. THEY WERE UNABLE TO CONFIRM HOW THE ESOPHAGEAL FISTULA WAS DISCOVERED AND CONFIRMED. THEY WERE UNABLE TO CONFIRM WHAT MEDICAL INTERVENTION WAS PROVIDED. THE PATIENT WAS IN STABLE CONDITION. THERE WERE NO ISSUES DURING THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES ON THE DAY OF THE PROCEDURE AND THAT THE PATIENT LEFT IN "GREAT CONDITION". THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. INTERVENTION PROVIDED WAS SURGERY AND THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPI

  Patient problems: Fistula

  MAUDE report 16943364 ↗
• DeathMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US). THE PATIENT DEVELOPED AN ESOPHAGEAL FISTULA AND CEREBROVASCULAR ACCIDENT AND ULTIMATELY PASSED AWAY. IT WAS REPORTED THAT AFTER COMPLETING THE PROCEDURE ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WITH AN ATRIAL ESOPHAGEAL FISTULA. THEY STATED THAT THE INFORMATION PROVIDED WAS LIMITED. THE PATIENT EXPIRED ON (B)(6) 2023. THE PATIENT WAS TREATED AT ANOTHER HOSPITAL. THEY STATED BEING NOTIFIED TODAY OF THE EVENT AND THE MEDICAL DIRECTOR IS ABLE TO PROVIDE MORE INFORMATION IF NEEDED. A REQUEST WAS SENT TO THE CALLER FOR INFORMATION ON THE SMARTABLATE¿ SYSTEM RF GENERATOR (US), BUT THE CALLER EMAILED BACK WITH A RESPONSE FROM THE MEDICAL DIRECTOR NOT BEING CONCERNED WITH HAVING THE SMARTABLATE¿ SYSTEM RF GENERATOR (US) EVALUATED SINCE THE GENERATOR HAS BEEN INVOLVED IN MULTIPLE CASES IN THE TIME BETWEEN THE ADVERSE EVENT AND NOW AND THEY HAVE NOT SEEN ANY OTHER INCIDENTS. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS ADMITTED TO ANOTHER

  Patient problems: Fistula; Stroke/CVA

  MAUDE report 16903483 ↗
• InjuryFeb 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) . THE PATIENT SUFFERED AN ESOPHAGEAL INJURY. IT WAS REPORTED THAT AFTER AN ATRIAL FIBRILLATION CASE HAD COMPLETED ON (B)(6), 2022, THAT PATIENT RETURNED TO THE HOSPITAL ON (B)(6), 2022, AND IT WAS NOTICED THAT THE PATIENT HAD AN "ESOPHAGEAL INJURY." THEY REPORTED THAT THE PATIENT WAS THEN HOSPITALIZED. THEY BELIEVE THAT THE PATIENT IS IN STABLE CONDITION, BUT THEY COULD NOT CONFIRM THE INFORMATION. THEY DO NOT HAVE ANY OTHER EVENT DETAILS AVAILABLE AT THE TIME OF THE CALL. THEY ARE DECLINING SMARTABLATE GENERATOR SERVICE AT THIS TIME. THEY ARE REQUESTING DOCUMENTATION ONLY. DISPATCH WAS APPROVED BY (B)(6). THE LOT NUMBER OF THE CATHETER IS UNKNOWN. THE ADVERSE EVENT WAS DISCOVERED AFTER USE OF BIOSENSE WEBSTER PRODUCTS. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PROCEDURE. INTERVENTION PROVIDED WAS UNKNOWN. OUTCOME OF THE ADVERSE EVENT WAS UNKNOWN. PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT DUE TO THE ESOPHAGEAL INJURY. RELEVANT TESTS

  Patient problems: Fistula

  MAUDE report 16439940 ↗
• DeathFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE THAT INCLUDED USE OF A SMARTABLATE GENERATOR AND A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND EXPERIENCED ESOPHAGEAL FISTULA. THE PATIENT SUBSEQUENTLY DIED. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT THE PHYSICIAN REPORTED A PATIENT WHO PASSED AWAY IN 2019 DUE TO AN ESOPHAGEAL FISTULA. THIS WAS POST ATRIAL FIBRILLATION ABLATION PROCEDURE. ADVERSE EVENT OCCURRED AFTER THE PATIENT HAD LEFT THE PROCEDURE. THE BWI REPRESENTATIVE REPORTED THAT HE IS UNAWARE OF THE DATE OF DEATH, AS WELL AS THE PROCEDURE DATE. THE BWI REPRESENTATIVE WAS MADE AWARE OF THIS EVENT ON 18-JAN-2023 AND MADE THE CALL FOR DOCUMENTATION PURPOSES. THE ADVERSE EVENT WAS DISCOVERED POST PROCEDURE. A TRANSSEPTAL PUNCTURE WAS PERFORMED. FORCE VISULAIZATION FEATURES INCLUDED DASHBOARD. VISITAG PARAMETERS FOR STABILITY WERE 2.5 MM, 6 SECONDS, FOT 25% FOR 3 GRAMS. ADDITIONAL FILTER USED WAS RESPIRATORY. COLOR OPTION WAS FTI LIMITED TO 400.

  Patient problems: Fistula

  MAUDE report 16383394 ↗
• InjuryJan 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A 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 AN ESOPHAGEAL FISTULA AND REQUIRED SURGICAL INTERVENTION. IT WAS REPORTED BY THE CALLER, THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE, THAT THERE WAS AN ISSUE AFTER A CASE THAT MAY HAD HAPPEN AT THE BEGINNING OF (B)(6) 2022. THE CALLER STATED NOT TO KNOW THE EXACT DATE OF THE PROCEDURE AND PROVIDED BEST ESTIMATE DATE OF (B)(6) 2022. THE PHYSICIAN IN A CASUAL CONVERSATION WITH THE CALLER MENTION A FISTULA THAT WAS DISCOVERED ON A VISIT TO THE EMERGENCY ROOM AFTER THE PATIENT REPORTED HAVING TROUBLE SWALLOWING WHILE EATING. THE CALLER STATED THAT THE PATIENT HAS THEN BEEN TREATED AND HAD GONE THROUGH SURGERY AND RECOVERY. THE CALLER STATED THAT THE PHYSICIAN MENTIONED THE PATIENT HAD ESOPHAGEAL ISSUES PRIOR TO THE PROCEDURE. THE CALLER ALSO STATED THAT HE WORKS WITH THE PHYSICIAN ON A DAILY BASIS AND KNOWS THE FLOW OF THE PHYSICIAN. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE ADVERSE EVENT WAS DISCOVERED POST USE. PATIENT REQUIRED SURGERY

  Patient problems: Fistula

  MAUDE report 16219205 ↗
• InjuryNov 23, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 34-YEAR-OLD MALE PATIENT 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 A CEREBROVASCULAR ACCIDENT REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT AFTER AN AFIB CASE, THE PATIENT SUFFERED A STROKE. THERE WERE NO VISIBLE SIGNS ON THE PATIENT DURING THE PROCEDURE. BEFORE THE PROCEDURE, THEY NOTICED THE PATIENT HAD AN IMPLANTED DEVICE, A POSSIBLE PACEMAKER/DEFIBRILLATOR WHICH HAD GROWTH BUILDUP. AFTER SOME ABLATION THEY NOTICED A RISE IN IMPEDANCE AND THE FLUID WAS NOT FLUSHING PROPERLY WHICH CUT OFF ABLATION FROM THE GENERATOR, SO THEY REMOVED THE CATHETER FROM THE BODY. CHAR WAS DISCOVERED ON THE TIP OF THE CATHETER AND WHEN CHECKING THE SETTINGS ON THE SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THEY NOTICED THAT IT WAS SET TO A 4MM CATHETER INSTEAD OF THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. DURING THE POST-PROCEDURE CHECK, THEY NOTICED THE GROWTH WAS GONE FROM THE IMPLANTED DEVICE. AFTER THE PROCEDURE THE STAFF NOTICED THAT THE PATIENT BEGAN ¿FORGET

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 15857350 ↗
• InjuryNov 14, 2022Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD FEMALE PATIENT (DATE OF BIRTH (B)(6) 1955, WEIGHING 132 KILOGRAMS) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT SUFFERED A BURN WITH BLISTERS WHERE GROUNDING PAD WAS. IT WAS REPORTED THAT A BURN ON THE GROUNDING PAD SITE WAS DISCOVERED ON THE PATIENT AFTER THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS IN THE RECOVERY ROOM. THERE WERE BLISTERS DISCOVERED ON THE PATIENT WHERE THE GROUNDING PAD WAS PLACED. BURN OINTMENT WAS APPLIED IN RECOVERY ROOM. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS A BWI PRODUCT MALFUNCTION, THE GROUNDING PAD CAME OFF THE PATIENT AND WHEN RF WAS DELIVERED LEFT A BURN ON THE PATIENT'S BACK.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15795260 ↗
• DeathNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 54-YEAR-OLD MALE PATIENT 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 AN ESOPHAGEAL FISTULA ULTIMATELY RESULTING IN DEATH. IT WAS REPORTED THE BIOSENSE WEBSTER INC (BWI) REPRESENTATIVE HEARD FROM THE LAB STAFF AT THE FACILITY THAT A PATIENT DIED OF AN ESOPHAGEAL FISTULA SOMETIME AFTER THE PROCEDURE. THE BWI REPRESENTATIVE DOES NOT KNOW WHEN THE ADVERSE EVENT WAS DISCOVERED. THE PHYSICIAN HAS NOT DISCUSSED THIS EVENT WITH THE BWI REPRESENTATIVE, THIS EVENT WAS REPORTED TO THEM BY THE LAB STAFF AT THE FACILITY. TO THE BWI REPRESENTATIVE¿S KNOWLEDGE, THERE WAS NO AN ADVERSE EVENT DURING THE PROCEDURE WHICH OCCURRED ON (B)(6) 2022. THE BWI REPRESENTATIVE WAS NOTIFIED BY THE EP LAB STAFF AT THE FACILITY ON 10/07/2022 THAT A PATIENT THAT HAD PULMONARY VEIN ISOLATION ON (B)(6) 2022 AND HAD EXPIRED ON (B)(6) 2022. THE PHYSICIAN AND THE BWI REPRESENTATIVE HAVE NOT HAD A DISCUSSION REGARDING WHAT THE PATIENTS CAUSE OF DEATH IS THOUGHT TO BE. THE ASSESSMENT OF ESOPHAGEAL INJURY OR FISTULA WAS VERBALIZED TO THE BWI REPRE

  Patient problems: Fistula

  MAUDE report 15726242 ↗
• DeathOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT SUFFERED AN ESOPHAGEAL FISTULA AFTER THE PROCEDURE WHICH RESULTED IN THE PATIENT¿S DEATH. IT WAS REPORTED THAT WHEN THE BWI REPRESENTATIVE WALKED INTO THE ACCOUNT, THEY WERE NOTIFIED THAT A PATIENT THEY DID A POSTERIOR WALL ISOLATION PROCEDURE ON (B)(6) 2022, DIED APPROXIMATELY A WEEK LATER AT ANOTHER HOSPITAL. THE BWI REPRESENTATIVE WAS NOT THERE AT THE INITIAL PROCEDURE AND HAS NO INFORMATION ABOUT THE PROCEDURE. THE BWI REPRESENTATIVE WAS INFORMED ON (B)(6) 2022, ABOUT THIS EVENT WHICH HAPPENED AT LEAST 6-7 WEEKS EARLIER. FROM WHAT THE BWI REPRESENTATIVE UNDERSTOOD, THE PATIENT HAD AN ESOPHAGEAL FISTULA THAT CAUSED HER DEATH. NO ADDITIONAL PATIENT, PRODUCT OR PROCEDURE DETAILS ARE AVAILABLE.

  Patient problems: Fistula

  MAUDE report 15541166 ↗
• InjuryJul 13, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE IN (B)(6) 2020 WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT SUFFERED AN ESOPHAGEAL FISTULA REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. AFTER AN ATRIAL FIBRILLATION CASE COMPLETED, WITHIN A WEEK OR TWO OF THE CASE, AN ATRIO-ESOPHAGEAL FISTULA WAS NOTICED IN THE PATIENT. THE PATIENT GOT ON AN AIRPLANE AGAINST THE ADVICE FROM THE DOCTOR AND THEN FELT UNWELL OR "CRUMMY." THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER) AND THEN THE PATIENT WAS ADMITTED INTO SURGERY. THE BWI REPRESENTATIVE DID NOT HAVE ANY OTHER EVENT DETAILS AVAILABLE AT THE TIME OF THE CALL. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN¿S OPINION IS THAT IT HAD NOTHING TO DO WITH THE PRODUCT. IT WAS JUST AN UNFORTUNATE EVENT AS NO SIGNS INDICATED US TO A FISTULA OCCURRING I.E. ESOPHAGEAL TEMPERATURE WAS CONSTANTLY MONITORED AND DID NOT RISE MORE THAN 0.5 DEGREES C BEFORE PHYSICIAN WOULD MOVE TO A DIFFERENT LOCATION. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. THE BW

  Patient problems: Fistula

  MAUDE report 15008865 ↗
• DeathMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT WITH A DATE OF BIRTH OF (B)(6) 1946 UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT SUFFERED AN ESOPHAGEAL FISTULA REQUIRING SURGICAL INTERVENTION AND ULTIMATELY RESULTING IN DEATH. IT WAS REPORTED THAT AN ESOPHAGEAL FISTULA WAS DISCOVERED A MONTH AFTER A PERSISTENT A-FIB CASE WHICH OCCURRED ON 24-MAR-2022. THE PATIENT WAS EXPERIENCING CHILLS AND DISCOMFORT ABOUT A MONTH AFTER THE PROCEDURE AND WENT TO THE EMERGENCY ROOM. AN ESOPHAGEAL FISTULA WAS CONFIRMED BY ULTRASOUND IMAGING BUT THAT THEY ARE UNSURE OF THE TYPE OF ULTRASOUND IMAGING USED. THEY ATTEMPTED TO STENT THE ESOPHAGEAL FISTULA AS INTERVENTION, BUT THE PATIENT PASSED AWAY 2-3 DAYS FOLLOWING THE STENT PROCEDURE. THE PHYSICIAN WAS UNSURE OF THE REASON FOR THE INJURY OR DEATH. AFTER THE BIOSENSE WEBSTER INC REPRESENTATIVE REVIEWED THE CASE WITH THE PHYSICIAN, IT WAS THE PHYSICIAN¿S OPINATION THAT EVERYTHING WAS WITHIN PARAMETERS AND THERE WERE NO OPERATOR ERRORS OR INCREASED FORCE ERRORS DURING THE PROCEDURE. THIS ADVERSE EVENT WAS DISCOVERED

  Patient problems: Fistula

  MAUDE report 14442424 ↗
• InjuryApr 12, 2022Activation, Positioning or Separation Problem; Patient Device Interaction Problem; Activation, Positioning or Separation Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT SUFFERED A CEREBROVASCULAR ACCIDENT REQUIRING PROLONGED HOSPITALIZATION. DURING THE CASE A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS IN USE FOR ABLATION BUT THE INCORRECT SETTINGS FOR THE CATHETER WERE SET ON THE SMARTABLATE® GENERATOR. THE CATHETER WAS SET AS A 4MM CATHETER AND THE COOLING WAS ALWAYS IN LOW FLOW. THE PHYSICIAN ASKS FOR 50WATTS RF DELIVERY AND AN ISSUE WITH IMPEDANCE BEGAN TO DISPLAY AFTER SOME TIME. AFTER REALIZING THE WRONG SETTING WERE BEING USED, THE BWI REPRESENTATIVE SUGGESTED FOR THE CATHETER BE PULLED OUT AND INSPECTED. THE PHYSICIAN PULLED THE CATHETER OUT AND FOUND CHAR ON THE CATHETER. THE CHAR WAS CLEANED UP, BUT THE PHYSICIAN REQUESTED A NEW CATHETER TO CONTINUE WITH THE CASE. CATHETER SETTINGS SELECTED ON THE GENERATOR WERE CHANGED BY THE STAFF TO THE WATTS THE DOCTOR PREFERS ON A 4 MM SETTING. POST-ABLATION AROUND 45 MINS AFTER THE PROCEDURE THE PATIENT WAS IN STABLE CONDITION. THE BWI REPRESENTATIVE

  Patient problems: Stroke/CVA

  MAUDE report 14080771 ↗
• InjuryMar 24, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT 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 AN ESOPHAGEAL FISTULA REQUIRING SURGICAL INTERVENTION. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2022 DUE TO A COMPLICATION WITH FROM THE ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE COMPLETED ON (B)(6) 2022. THE PATIENT RETURNED WITH AN ESOPHAGEAL FISTULA FOR A TREATMENT. THE ESOPHAGEAL INJURY WAS CONFIRMED ON (B)(6)2022. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. EMERGENCY CARDIOTHORACIC SURGERY WAS REQUIRED. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS UNKNOWN, HOWEVER, THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT AND WAS STILL HOSPITALIZED IN AN UNKNOWN CONDITION. A SMARTABLATE¿ SYSTEM RF GENERATOR (US) WAS USED IN THE ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE. IT WAS USED IN POWER CONTROL MODE AT 50W WITH THE CORRECT CATHETER SETTING SELECTED. THE SMARTABLATE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQ

  Patient problems: Fistula

  MAUDE report 13873885 ↗
• InjuryFeb 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) THE PATIENT SUFFERED AN ESOPHAGEAL FISTULA AND WAS HOSPITALIZED. AFTER AN ATRIAL FIBRILLATION CASE HAD COMPLETED, AN ESOPHAGEAL FISTULA WAS NOTICED IN THE PATIENT. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER), BUT IT WAS UNKNOWN SPECIFICALLY WHAT DAY THEY WERE ADMITTED. THE PATIENT WAS INTUBATED AS OF THE TIME OF THE INITIAL CALL. THERE IS NO FURTHER INFORMATION ABOUT INTERVENTION THAT WAS PERFORMED. THE CALLER REPORTED THAT IT WAS UNKNOWN IF THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Fistula

  MAUDE report 13530344 ↗