ThermoCool SmartTouch D133602Recalls & reported problems

Summary

The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 10846835009002), received between Jun 16, 2016 and Jun 15, 2026 — classified as 8 deaths, 124 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (40 reports).

8 other recalls cover devices cleared under the same FDA submission (P030031, P040036); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 225 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND THERE WAS SIGNAL INTERFERENCE WAS OBSERVED ON ALL CHANNELS. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT WHEN CONNECTING THE ST CATHETER, BS ECG AND OTHER SIGNALS (INCLUDING THE ST SIGNALS) WERE VERY DISTORTED. CHANGING CABLE DIDN'T SOLVE THE ISSUE. CHANGING CATHETER DID. THERE WAS NO PATIENT CONSEQUENCE. ON 18-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING SIGNAL INTERFERENCE WAS OBSERVED ON ALL CHANNELS ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. THE PHYSICIAN DID NOT HAVE ANY INTACT ECG SIGNAL AVAILABLE TO MONITOR PATIENT HEART RHYTHM, THEY HAD TO REMOVE THE CATHETER. BASED ON THE INFORMATION RECEIVED INDICATING THERE WERE NO SIGNALS AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM DURING THE PROCEDURE, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499457 ↗
• MalfunctionMay 12, 2026Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. DURING THE PROCEDURE, THE CATHETER RECEIVED A SENSOR ERROR 105. THE CABLE WAS REPLACED BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151014 ↗
• InjuryApr 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED DRAINAGE. DURING THE PROCEDURE THE PATIENT BECAME HYPOTENSIVE. ECHOCARDIOGRAPHY REVEALED A PERICARDIAL EFFUSION CAUSING CARDIAC TAMPONADE. THE BLOOD WAS DRAINED AND THE PATIENT WAS STABILIZED. PATIENT WENT TO ICU (INTENSIVE CARE UNIT) AND WAS STABLE 2 HOURS AFTER THE PROCEDURE. THE PHYSICIAN SUSPECTED THAT THE CARDIAC TAMPONADE MAY HAVE OCCURRED DURING THE TRANSSEPTAL PUNCTURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 24928049 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REDO PVI (PULMONARY VEIN ISOLATION) ABLATION WITH A THERMOCOOL SMARTTOUCH AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. IT WAS REPORTED THAT THE PROCEDURE WENT QUITE WELL AT THE BEGINNING. FOR THE MEDICAL TEAM, "IT SEEMED LIKE A BIT OF STRUGGLING" GOING TO THE LA (LEFT ATRIUM) AFTER THE TRANSSEPTAL PUNCTURE (1 PUNCTURE TWO CATHETERS THROUGH THE SAME HOLE). AFTER SOME SOME MINUTES THE PHYSICIAN MANAGED TO GO TO THE LA WITH BOTH CATHETERS. EVERYTHING SEEMED FINE AND AFTER THE MAP THE ABLATION STARTED AT THE POSITIONS WHERE THE VEINS WERE STILL OPEN. AFTER 11 ABLATION POINTS, THE NURSES AND PHYSICIAN RECOGNIZED A DROP IN THE BLOOD PRESSURE AND DID ULTRASOUND (TTE - TRANSTHORACIC ECHOCARDIOGRAM) WHICH SHOWED A TAMPONADE. EPICARDIAL PUNCTURE WAS PERFORMED IMMEDIATELY AND MEDICATION AGAINST HEPARIN (HAD BEEN GIVEN BEFORE IN NORMAL WORKFLOW) WAS GIVEN. THE BLOOD WHICH WAS SUCKED OUT OF THE EPICARDIAL VOLUME WAS REINTRODUCED. SINCE THE HOLE DIDN¿T CLOSE BY ITSELF, A HEART SURGEON HAD TO COME TO OPEN THE CHEST AND CLOSE THE HOLES. SHE FOUND 2 HOLES TO CLOSE WHICH WHERE AT THE ROOF OF THE

  Patient problems: Cardiac Perforation

  MAUDE report 24734959 ↗
• InjuryFeb 23, 2026Patient Device Interaction Problem

  AFTER ATRIAL FIBRILLATION + ATYPICAL FLUTTER ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER, THE PATIENT EXPERIENCED CARDIAC ARREST AND CARDIAC TAMPONADE TREATED WITH SURGERY TO CLOSE THE TAMPONADE. THE REPORT INDICATED THAT AFTER THEY FINISH ATRIAL FIBRILLATION + ATYPICAL FLUTTER ABLATION PROCEDURE, THE PATIENT SUFFERED A CARDIAC ARREST IN THE RECOVERY ROOM. AM ECHOCARDIOGRAPH DISCOVERED THAT THE PATIENT HAD CARDIAC TAMPONADE. THE INTERVENTIONAL HEMODYNAMICS TEAM PERFORMED SURGERY PROCEDURE TO CLOSE THE TAMPONADE, AND AS OF TWO HOURS AFTER ITS COMPLETION THE PATIENT REMAINS HEMODYNAMICALLY STABLE. AFTER SURGERY, THE PATIENT IS STABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION AND ADDITIONAL INFORMATION ABOUT THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED, IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: Cardiac Arrest; Cardiac Perforation

  MAUDE report 24424778 ↗
• InjuryFeb 12, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. TAMPONADE OCCURRED DURING PROCEDURE. PERICARDIOCENTESIS WAS PERFORMED AND PATIENT WAS TAKEN INTO OR (OPERATING ROOM) BECAUSE OF THE TAMPONADE AND FOR SAFETY REASONS TO DO THE PERICARDIOCENTESIS TO STOP THE BLEEDING, NO SURGICAL INTERVENTION WAS NEEDED. ACCORDING TO THE BWI REPRESENTATIVE, THEY REMOVED THE SHEATHS IN THE OPERATING ROOM AND THE BLEEDING WAS STOPPED.

  Patient problems: Cardiac Tamponade

  MAUDE report 24329260 ↗
• MalfunctionJan 14, 2026Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. THE CONTACT OF THE CATHETER WAS NOT COHERENT DURING THE PROCEDURE. IT ALWAYS DETECTED A CONTACT WITH A CATHETER EVEN IF IT WAS THE ONLY CATHETER INTO THE ATRIUM. WE CHANGED FIRST THE CABLE, A NEW CATHETER RESOLVED THE ISSUE. WE ALSO SAW SOME BLOOD IN THE ROTOR OF THE DEFECTIVE CATHETER. NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2025 OBSERVED REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE IN THE SURFACE OF THE PEBAX ON (B)(6) 2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070043 ↗
• MalfunctionJan 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT WHEN THE CATHETER ENTERED THE CHAMBER, THERE WAS AN ISSUE WITH THE VECTOR AND WITH HIGH PRESSURE INDICATION WHILE THERE WAS NO CARDIAC SIGNAL. THE CABLE WAS CHANGED AND THEN THE CATHETER WAS CHANGED TO ANOTHER AND THE ISSUE WAS RESOLVED. THE CUSTOMER'S REPORTED FORCE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 9 DECEMBER 2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL (PRESUMABLY BLOOD) INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954264 ↗
• MalfunctionDec 23, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE CATHETER HAD FLUID POURING OUT AND CANNOT BE CONTROLLED BY IRRITATION PUMP. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED IRRIGATION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 2-DEC-2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885497 ↗
• InjuryDec 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE DURING A BWI SPONSORED CLINICAL TRIAL WITH A THERMOCOOL SMARTTOUCH CATHETER AND THE PATIENT EXPERIENCED 3RD DEGREE AV BLOCK REQUIRING A PACEMAKER AND PROLONGED HOSPITALIZATION. ON (B)(6) 2025 START DATE, THE PATIENT RECEIVED INDEX CARDIAC ABLATION, AND SITE AWARENESS DATE OF (B)(6) 2025, THE PATIENT EXPERIENCED 3RD DEGREE AV BLOCK (AE# 1). DURING SUPERVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE, WITH THERMOCOOL SMARTTOUCH CATHETER, CATEGORIZED AS SEVERE AND SERIOUS, REQUIRING IN-PATIENT OR PROLONGED HOSPITALIZATION, WITH AN ADMISSION DATE OF (B)(6) 2025 AND DISCHARGED DATE OF (B)(6) 2025. THE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. THE RELATIONSHIP TO STUDY DEVICE IS NOT RELATED. THE RELATIONSHIP TO THE INDEX STUDY PROCEDURE IS CAUSAL AND THE EVENT IS UNEXPECTED/UNANTICIPATED. THE OUTCOME IS RECOVERED/RESOLVED WITH AN END DATE OF (B)(6) 2025. INTERVENTION IS SURGERY WITH A PACEMAKER. DATE EVENT FIRST REPORTED TO BE A SERIOUS ADVERSE EVENT (SAE) WAS (B)(6) 2025. NO STEAM POP REPORTED. COMPUTE

  Patient problems: Heart Block

  MAUDE report 23711685 ↗
• InjuryOct 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIAL PUNCTURE AND THEN TAKEN INTO SURGERY TO STOP THE BLEEDING. DURING THE ABLATION PHASE, WHILE IN THE ISTHMUS-CAVAL TRACT (ICT), THE ANESTHESIOLOGIST NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE. THE DOCTOR QUICKLY SUGGESTED AN ULTRASOUND AND NOTICED THAT THERE WAS A PERICARDIAL EFFUSION. THEY HAD TO PERFORM A PERICARDIAL PUNCTURE TO DRAIN THE BLOOD AND WERE ABLE TO REMOVE A SIGNIFICANT AMOUNT OF BLOOD TO STABILIZE THE PATIENT. HOWEVER, THEY WERE UNABLE TO STOP THE BLEEDING, SO THE PATIENT HAD TO BE TAKEN INTO SURGERY TO STOP THE BLEEDING. THE ABLATION ON THE ICT WAS WITH 40W, POWER CONTROL, TEMPERATURE CUT OFF: 50 DEGREES, IMPEDANCE CUT OFF: 15 OHM/0.5SEGS. AFTER THIS HAPPENED, THEY CHECKED TO SEE IF ANY OF THE APPLICATIONS WERE FAULTY, IF THERE WERE ANY FORCE PEAK OR IMPEDANCE JUMP, BUT COULD NOT FIND ANYTHING UNUSUAL. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 50 MINUTES. THE ACTION TAKEN WAS THAT THE PROCEDURE WAS FINISHED, BUT THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE PATIENT WAS

  Patient problems: Cardiac Tamponade

  MAUDE report 23429979 ↗
• MalfunctionJul 9, 2025Crack; Crack

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE SPRING OF THE CATHETER WAS BROKEN. THE ISSUE WAS IDENTIFIED BEFORE THE DEVICE HAD BEEN INSERTED INTO THE PATIENT'S BODY. THE ABNORMALITY OCCURRED WHEN ATTEMPTING TO FLEX THE CATHETER. CONTROLLING IT AT THE HANDLE DID NOT ALLOW THE CATHETER TO FLEX, AND THE SPRING'S CONDITION APPEARED UNUSUAL. NO FURTHER DETAILS WERE PROVIDED REGARDING COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461142 ↗
• InjuryJun 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WPW (WOLFF PARKINSON WHITE) PARAHISSIAN ABLATION WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED COMPLETE HEART BLOCK THAT REQUIRED PACING AND MEDICATION. THE DOCTOR ABLATED FOR 18S AT 35W 2CM AWAY FROM THE HIS. THE MEDICAL TEAM WAS PACING IN THE VENTRICLES DURING ABLATION. AFTER THE ABLATION, THEY STOPPED THE PACING. THEY HAD A COMPLETE AV (ATRIOVENTRICULAR) BLOCK FOR ABOUT 8 SEC. THE MEDICAL TEAM PACED AGAIN AND PUT SOME ISUPREL. THEY THEN STOPPED THE PACING AND THE ISUPREL. THE PATIENT PARTIALLY RECOVERED AND WAS CONDUCTING ONE EVERY TWO BEATS. THE TEAM WAITED FOR 15 MINUTES. THE PATIENT WAS STILL CONDUCTING ONLY ONE EVERY TWO BEATS WHEN THEY LEFT THE OPERATING ROOM.

  Patient problems: Heart Block

  MAUDE report 22355878 ↗
• MalfunctionJun 11, 2025Device Alarm System; Obstruction of Flow; Device Alarm System; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH THERMOCOOL SMARTTOUCH CATHETER AND AN IRRIGATION ISSUE OCCURRED WITH THE DEVICE USED IN THE PATIENT. AFTER 6 ABLATION POINTS, CONTINUOUS BUBBLE ALARM. THE TUBING WAS CHANGED AND FLUSHED AGAIN BUT STILL BUBBLES AFTER A COUPLE OF SECONDS OF ABLATION. THE ABLATION CATHETER WAS EXTRACTED OUT OF THE PATIENT AND THE FLUSH WAS INSPECTED. ONLY ONE HOLE OPEN OF THE 6 HOLES. CATHETER WAS CHANGED WITH A NEW ONE AND PROBLEM WAS SOLVED. THE PROCEDURE WAS DELAYED BY 10 MINUTES DUE TO THE REPORTED ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON THE PATIENT. BUBBLE ERROR ON THE SMART ABLATE GENERATOR. STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS TO FLUSH THE TUBING OUT OF THE PATIENT UNTIL BUBBLE ERROR DISAPPEARS (T LOCK). THE BUBBLE ALARM WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS LOW. THE IRRIGATION ISSUE WITH THE DEVICE USED IN THE PATIENT WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22190811 ↗
• MalfunctionMay 27, 2025Device Contamination with Body Fluid; Obstruction of Flow; Device Contamination with Body Fluid; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND ALL THE PORES WERE IRRIGATING PROPERLY. AFTER AN ATRIAL FIBRILLATION ABLATION PROCEDURE, CHARRING WAS OBSERVED AT THE TIP OF THE CATHETER ONCE IT WAS OUT. AT THE BEGINNING OF THE PROCEDURE, BEFORE INSERTING THE CATHETER, THE IRRIGATION SYSTEM WAS CHECKED FOR PROPER FUNCTIONING. AFTER, WHEN THE CATHETER WAS OUT, IT WAS OBSERVED THAT NOT ALL PORES WERE IRRIGATING PROPERLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087262 ↗
• InjuryMar 31, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL SF AND THE PATIENT EXPERIENCED PERICARDITIS THAT REQUIRED HOSPITALIZATION. THE CALLER SAYS SHE HAS NOT HAD PERICARDITIS IN A LONG TIME USING SMART TOUCH UNIDIRECTIONAL SF AND HAS QUESTIONED WHETHER THE NGEN SETTINGS MAY HAVE CAUSED THIS; HOWEVER, THERE WERE NO SPECIFIC DEVICE MALFUNCTIONS NOTED WITH THE NGEN. THE WORKFLOW HAS ALWAYS BEEN, POSTERIOR: 10SECOND CUT OFF ¿ 50W. ANTERIOR: NO TIME CUT OFF ¿ ABLATION INDEX TARGET OF 400. PRE-FLOW WAS SET AT: 1- 2 SEC. POST FLOW: 0 SEC. ABLATION WAS NOT EXCESSIVE, AND FORCE WAS REASONABLE WITH AN AVERAGE OF 5-15G. ADDITIONAL INFORMATION WAS RECEIVED ON 27-MAR-2025 WHICH INDICATED THAT NO INTERVENTION WAS REQUIRED, HOWEVER, THE PATIENT WITH PERICARDITIS WAS RE-ADMITTED THE NEXT DAY WITH CHEST PAIN BUT WERE DISCHARGED WITHIN 24 HOURS. THE PATIENT FULLY RECOVERED. RELEVANT LABS AND TESTS INCLUDED: ECHOES SHOWED NO EFFUSION, TROPONINS WERE ELEVATED, ECG SHOWED SIGNS OF PERICARDITIS. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED. IT WAS REPORTED THAT ACTIVATED CLOTTING TIME (ACT) WAS WITHIN

  Patient problems: Pericarditis

  MAUDE report 21733708 ↗
• MalfunctionFeb 19, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT TEMPERATURE CAN¿T DISPLAY. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED FORCE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON (B)(6) 2025, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A HOLE IN THE PEBAX AND A REDDISH MATERIAL INSIDE THE PEBAX. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿HOLE¿ IN THE PEBAX AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21407311 ↗
• MalfunctionFeb 13, 2025Insufficient Cooling; Obstruction of Flow; Output below Specifications; Insufficient Cooling; Obstruction of Flow; Output below Specifications

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND AN IRRIGATION ISSUE OCCURRED. WHEN ABLAITING THE TEMPERATURE RAISED VERY FAST AND THE POWER WASN¿T RAISING. ONLY ONE OF THE PORUS OF THE ST WAS IRRIGATING. THE CATHETER WAS CHANGED AND PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A 5 MINUTE DELAY IN THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375369 ↗
• MalfunctionJan 28, 2025Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem; Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE WITH A THERMOCOOL SMARTTOUCH FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE IN THE SURFACE OF THE PEBAX. INITIALLY, IT WAS REPORTED THAT THERE WAS AN EXTREMELY HIGH FORCE READING WERE DISPLAYED, ONLY WHEN COMING ON WITH RADIOFREQUENCY (RF) ABLATION. THEY UNPLUGGED, REPLUGGED, AND CHANGED THE CABLE AND THE ISSUE WAS NOT RESOLVED. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. ONCE THEY WITHDREW THE CATHETER FROM THE BODY, THEY NOTICED THERE WAS BLOOD INSIDE THE SPRING SECTION OF THE CATHETER. THERE WAS NO PATIENT CONSEQUENCE. THE FOREIGN MATERIAL (BLOOD) AND FORCE ISSUE WERE ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 28-JAN-2025, REDDISH MATERIAL AND A HOLE IN THE SURFACE OF THE PEBAX WERE NOTED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 28-JAN-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256681 ↗
• MalfunctionSep 11, 2024Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PERSISTENT ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND CHAR WAS NOTICED AT THE TIP OF THE ABLATION CATHETER AT THE END OF THE PROCEDURE. THERE WERE NO ERROR MESSAGES NOTED BY THE PHYSICIAN. THERE WERE NO TEMPERATURE ISSUES EITHER. THE PATIENT WAS ANTICOAGULATED AND THIS WAS MAINTAINED THROUGHOUT THE CASE. THE PHYSICIAN NOTED THAT THE CHAR WAS EXCESSIVE PER THEIR STANDARDS BUT DID NOT NECESSARILY INCREASE RISK TO THE PATIENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193644 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND THE CATHETER TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161923 ↗
• MalfunctionJul 25, 2024Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND SOME IRRIGATION HOLES WERE OCCLUDED. IT WAS REPORTED THE THERMOCOOL SMARTTOUCH CATHETER SEEMS SLIGHTLY OBSTRUCTED AND DOES NOT ALLOW TO ABLATE BECAUSE WHEN ABLATING WITH SMARTABLATE THE TEMPERATURE CUT-OFF WAS QUICKLY REACHED. ALSO WHEN FLUSHING THE CATHETER OUTSIDE OF THE PATIENT WE DON¿T SEE WATER COMING THROUGH EVERY HOLE AT THE TIP. ANOTHER CATHETER FROM A DIFFERENT LOT HAD TO BE USED. THERE WERE NO PATIENT CONSEQUENCES. ON 3-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ISSUE OCCURRED WHILE THE DEVICE WAS BEING USED ON THE PATIENT. THEY TRIED TO FLUSH THE IRRIGATION TUBING SET WITHOUT THE CATHETER AND THERE WAS NO ISSUE. WITH THE CATHETER DURING THE FLUSH THE WATER WAS NOT GOING THROUGH EACH HOLE HOMOGENEOUSLY. THERE WAS NO ERROR ON THE SMARTABLATE PUMP, ONLY ON THE SMARTABLATE GENERATOR. AS SUCH, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION BASED ON THE NEW INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833738 ↗
• MalfunctionJun 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ONE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER WAS RECEIVED BY THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB ON 19-JAN-2024 WITH NO ACCOMPANYING INFORMATION AND WAS PROCESSED ON 24-MAY-2024. THE DEVICE COULD NOT BE ASSOCIATED WITH AN EXISTING COMPLAINT. IN THE ABSENCE OF CLARIFYING INFORMATION, IT CANNOT BE DETERMINED WHY THIS DEVICE WAS RETURNED TO BWI. HOWEVER, VISUAL ANALYSIS REVEALED A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION AND A REDDISH MATERIAL INSIDE IT. AS A RESULT, THIS WILL BE REPORTED TO FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581793 ↗
• MalfunctionMay 31, 2024Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem; Device-Device Incompatibility; Temperature Problem; Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem; Device-Device Incompatibility; Temperature Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND OBSERVED WHITE AT THE TIP OF THE CATHETER. AT FIRST, NO TEMPERATURE WAS DISPLAYED ON THE SMARTABLATE AND ¿CATHETER TIP SENSOR ERROR¿ ESA REPORTES NO CARTO3. CHANGING THE CONNECTOR CABLE DID NOT SOLVE THIS ISSUE. CATHETER WAS REPLACED AND ERROR WAS SOLVED BUT THEY ENCOUNTERED ANOTHER PROBLEM. WHEN THE DOCTOR WAS GOING TO PULL THE CATHETER OUT, SHE FOUND SOME RESISTANCE. ONCE SHE WAS ABLE TO TAKE IT OUT, THE DOCTOR REPORTED SOMETHING WHITE AT THE TIP OF THE CATHETER. WE ARE NOT SURE IF THIS IS PART OF THE GUIDING SHEATH ((B)(4)) OR AN ANOMALY DURING FABRICATION OF THE CATHETER. PROCEDURE DELAYED 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. ONLY ONE CATHETER WAS INVOLVED IN THE COMPLAINT. FIRST, THE TEMPERATURE ERROR OCCURRED DUE TO THE SENSOR TIP ERROR, AND WHEN THIS CATHETER WAS GOING TO BE REPLACED AND THEREFORE, TAKING IT OUTSIDE THE PATIENT'S CHAMBER OF THE HEART, THE PHYSICIAN DESCRIBED THAT THE CATHETER WAS STUCK AND COULD NOT TAKE OUT UNTIL THE PHYSICIAN APPLIED UNUSUAL FORCE TO DO SO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19432868 ↗
• MalfunctionMay 2, 2024Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX SURFACE. TEMPERATURE ISSUE REPORTED AS NO TEMPERATURE AVAILABLE. NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 05-APR-2024, A HOLE WAS OBSERVED ON THE PEBAX SURFACE WITH REDDISH MATERIAL INSIDE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE ON THE PEBAX SURFACE ON 05-APR-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229400 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031, P040036. One submission often covers many models, so check the product and lot details in each record.

• Z-0169-2023 · Sep 7, 2022 · Open, Classified
  THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in con
• Z-0139-2015 · Oct 19, 2014 · Terminated
  ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
• Z-0979-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0982-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0981-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0980-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0983-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0057-06 · Aug 8, 2005 · Terminated
  Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R P