THERMOCOOL SMARTTOUCH SF D134703Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10846835009798), received between Oct 23, 2017 and Nov 19, 2025 — classified as 3 deaths, 53 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (31 reports).

8 other recalls cover devices cleared under the same FDA submission (P030031); 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 72 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION/TAMPONADE TREATED WITH DRAINED TAMPONADE. THE PERICARDIAL EFFUSION WAS VISIBLE ON TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) AFTER TRANSEPTAL PUNCTURE, AND THE ABLATION CATHETER WAS IN THE PATIENT'S RIGHT ATRIUM AT THIS TIME. THE INCREASED EFFUSION DURING THE PROCEDURE WAS TREATED WITH DRAINAGE. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT FOR 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THE OUTCOME OF THE ADVERSE EVENT FULLY RECOVERED (NO RESIDUAL EFFECTS). A NGEN GENERATOR AND PUMP WERE USED FOR THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 23591471 ↗
• InjuryJul 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) - PAROXYSMAL ABLATION AND THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT. THE PATIENT HAD A STROKE DURING RECOVERY POST PROCEDURE. A MAGNETIC RESONANCE IMAGING (MRI) WAS USED TO DIAGNOSE THE STROKE. THE FINDINGS ON BRAIN SCAN SHOWED ACUTE INFARCT DORSAL PONS. IT WAS REPORTED THAT THE PATIENT REMAINED IN THE HOSPITAL FOR MONITORING AND HAS RECOVERED. INTERVENTION INCLUDED ANTICOAGULANTS. PATIENT'S SYMPTOMS MOSTLY IMPROVED. DURING THE PROCEDURE, THERE WERE TWENTY-TWO (22) PULSED FIELD ABLATION (PFA) APPLICATIONS TO THE PULMONARY VEINS ONLY. THE THERMOCOOL SMARTTOUCH SF CATHETER WAS USED AT THE END OF THE PROCEDURE TO COMPLETE A CAVOTRICUSPID ISTHMUS (CTI) LINE IN THE RIGHT ATRIUM (4 RADIOFREQUENCY (RF) APPLICATIONS). THE ACTIVATED CLOTTING TIME (ACT) WAS THERAPEUTIC (365), AND THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE. PRE-ABLATION THROMBUS CHECK WAS PERFORMED. THERE WAS NO EVIDENCE OF CHAR, THROMBUS/CLOT THAT WERE NOTED DURING THE PROCEDURE. DURING THE ABLATION, THE PATIENT WAS IN SINUS RHYTHM. THE PATIENT DID NOT HAVE ANY ANATOMICAL ABNORMALITIES. THERE WERE TWO CATHETER EXCHANGES THAT OCCURRED DURING

  Patient problems: Stroke/CVA

  MAUDE report 22397098 ↗
• InjuryJun 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION ABLATION, AND THE PATIENT EXPERIENCED A STROKE. AFTER ABLATION, THE PATIENT WAS STABLE AND WAS TRANSPORTED TO THE POST OP AREA. THERE, THE PATIENT EXHIBITED SIGNS OF STROKE. THE PATIENT WAS TAKEN TO IMAGING AND MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH CONFIRMED A STROKE. THE PATIENT REMAINED STABLE AND WAS DISCHARGED THE NEXT DAY. NO INTERVENTION WAS DONE. THE PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION CONSISTING OF AN OVERNIGHT STAY. THERE WAS NO EVIDENCE OF CHAR OR BLOOD THROMBUS/CLOT DURING THE PROCEDURE. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. ACTIVATED CLOTTING TIME (ACT) BEFORE AND DURING ABLATION WAS 357 (ONLY ONE ACT). THERE WAS ONE TRANSSEPTAL PUNCTURE SITE PERFORMED. THE SHEATH WAS EXCHANGED ONCE, AND THE CATHETERS WERE EXCHANGED TWO TIMES. THERE WERE TWENTY-SIX (26) PULSED FIELD ABLATION (PFA) APPLICATIONS WERE DONE, WITH FOUR (4) APPLICATIONS ON THE LEFT ATRIAL (LA) ROOF, TWENTY-TWO (22) APPLICATIONS FOR PULMONARY VEIN ISOLATION (PVI), RADIOFREQUENCY (RF) APPLIC

  Patient problems: Stroke/CVA

  MAUDE report 22350092 ↗
• DeathJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORT INDICATED THAT DURING AFIB ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER, THE PATIENT EXPERIENCED BLOOD PRESSURE DROP 50/40, AND PERICARDIAL EFFUSION DISCOVERED WITH INTRACARDIAC ECHO. HEPARIN WAS STOPPED AND PROTAMINE WAS GIVEN. A PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN, REMOVING ABOUT 1300CC'S. OPEN REPAIR WAS THEN PERFORMED IN THE LAB TO CORRECT THE PERFORATION. THE PATIENT EXPIRED DURING THE SURGERY.

  Patient problems: Cardiac Perforation

  MAUDE report 22310874 ↗
• InjuryJun 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. AN HOUR INTO THE ABLATION, A PERICARDIAL EFFUSION WAS DISPLAYED FROM THE CARTOSOUND AND ULTRASOUND UNIT. THE PATIENT WAS ASYMPTOMATIC AND BLOOD PRESSURE WAS NORMAL BUT WAS NOT BEING SUPPORTED. A PERICARDIOCENTESIS WAS PERFORMED AND APPROXIMATELY 360 CC OF FLUID WAS WITHDRAWN. PATIENT WAS ALSO GIVEN PROTAMINE. THE CASE CONTINUED. NO FURTHER INTERVENTIONS WERE PLANNED.

  Patient problems: Cardiac Tamponade

  MAUDE report 22127836 ↗
• InjuryMay 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED THAT AFTER AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF (STSF), THE PATIENT EXPERIENCED EFFUSION THAT WAS TREATED WITH PERICARDIOCENTESIS. THE REPORT INDICATED THAT AFTER THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED. THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS ROTATED AND NOTICED THE EFFUSION. THE INJURY WAS VISUALLY CONFIRMED ON ICE. PERICARDIOCENTESIS WAS PERFORMED ON THE PATIENT, AND THE LAST KNOWN STATUS OF THE PATIENT WAS STABLE. AT THE TIME OF REPORTING, IT IS UNKNOWN WHAT CAUSED THE INJURY. PRIOR TO THE EVENT, IT WAS NOTED THAT THE DISTAL TIP OF THE VIZIGO SHEATH RIPPLED BACKWARDS WHILE IN THE BODY. THE SHEATH WAS REMOVED FROM THE BODY AND THE DILATOR WAS MOVED BACK AND FORTH WITHOUT RESOLUTION. THE VIZIGO SHEATH WAS REPLACED, AND THE ISSUE RESOLVED. THE PROCEDURE WAS CONTINUED. IT WAS NOTED THAT THE SHEATH WAS NOT RELATED TO THE EVENT, AND THE VIZIGO SHEATH AND THE STSF CATHETER WERE IN USE DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 22058463 ↗
• MalfunctionSep 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THERE WAS SOME PAPER STUCK ON THE CATHETER SHAFT THAT COULD NOT BE REMOVED. IT WAS REPORTED BY THE CALLER, A CLINICAL ACCOUNT SPECIALIST, THAT THERE WAS SOME PAPER STUCK ON THE CATHETER SHAFT AND IT WAS NOT ABLE TO BE REMOVED DUE TO ADHESIVE BEING ON IT. THE CATHETER WAS REPLACED AND IT WAS NOTICED THAT THE REPLACEMENT CATHETER HAD TUBING PROTECTING THE AREA WITH THE ADHESIVE FROM THE PACKAGING THAT HAD GOTTEN STUCK ON THE PRIOR CATHETER. THE CALLER STATED THE FAILURE OF THE PACKAGING MAY HAVE CAUSED THE ISSUE. THE CATHETER WAS REPLACED AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200140 ↗
• InjuryAug 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) / AFLUTTER ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AFTER ISOLATING PULMONARY VEINS IN THE LEFT ATRIUM, THE PHYSICIAN MOVED TO THE RIGHT ATRIUM AND ABLATED A CAVOTRICUSPID ISTHMUS (CTI) LINE. NON-SUSTAINED AFIB WAS INDUCED SO THEY DECIDED TO ISOLATE THE RIGHT ATRIUM (RA) APPENDAGE. THE PHYSICIAN ABLATED AT 50 WATTS, AND THREE QUARTERS OF THE WAY AROUND, THE APPENDAGE NOTICED A SMALL PERICARDIAL EFFUSION ON INTRACARDIAC ECHO. THE SOUNDSTAR CATHETER WAS IN THE RIGHT VENTRICLE (RV). THEY CONTINUED ABLATING SINCE THE PATIENT WAS STABLE. WHEN THEY FINISHED ISOLATING THE RIGHT ATRIAL APPENDAGE (RAA), THEY NOTICED A DROP IN THE PATIENT'S BLOOD PRESSURE. THE EFFUSION HAD GROWN TO A MODERATE SIZE. A PERICARDIOCENTESIS WAS PERFORMED, REMOVING BETWEEN 114 CC AND 140 CC OF FLUID, WHICH WAS REINTRODUCED TO THE PATIENT. THE PATIENT'S BLOOD PRESSURE STABILIZED. THE LAST KNOWN PATIENT STATUS WAS STABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 19934414 ↗
• MalfunctionJul 8, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THERE WAS A CATHETER SENSOR ERROR OF ¿MAGNETIC SENSOR APPEARS DISCONNECTED¿. THEY TRIED REPLACING THE CONNECTION CABLE, BUT THE ERROR DID NOT SOLVE. NO FORCE VALUES WERE RECORDED. AFTER REPLACING THE CATHETER, THE ERROR SOLVED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THE CUSTOMER'S REPORTED MAGNETIC SENSOR ERROR 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 14-JUN-2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND A REDDISH MATERIAL AND A HOLE IN THE SURFACE OF 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 19696976 ↗
• MalfunctionJul 1, 2024Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND AN IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT. HIGH TEMPERATURE READINGS WERE BEING DISPLAYED ON THE NGEN SYSTEM. THE CATHETER WAS FOUND TO BE OCCLUDED. THE TUBING WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE CASE CONTINUED WITHOUT FURTHER INCIDENT OR HARM. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOTICED WHILE THE DEVICE WAS USED ON THE PATIENT. THE DOCTOR TRIED TO ABLATE AND THE NGEN GAVE HIM A TEMPERATURE WARNING AND WOULD NOT ABLATE. THE EXACT ERROR NUMBER WAS UNKNOWN; HOWEVER, IT SAID SOMETHING ALONG THE LINES OF TEMPERATURE READING ERROR (TEMPERATURE ERROR) OR TEMPERATURE WARNING. THEY TRIED FLUSHING THE CATHETER A FEW TIMES AND IT APPEARED STUCK. THEY REPLACED THE CATHETER CABLE AND WHEN THAT DID NOT WORK, THEY PULLED OUT THE CATHETER TO CHECK FOR CHAR OR SOME OBSTRUCTION BEFORE FINALLY REPLACING THE ACTUAL CATHETER. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. THE TEMP CUTOFF VALUE WAS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645328 ↗
• MalfunctionJun 3, 2024Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER (STSF) AND THE CATHETER WOULD NOT FLUSH MID-CASE AND WAS OCCLUDED. THEY HIGH-POWER FLUSHED THE CATHETER WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. REPLACEMENT CATHETER REQUESTED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS INDICATED THAT THERE WAS NO ERROR NOTED ON THE NGEN IRRIGATION PUMP. ABLATION WOULD NOT INITIATE. A CATHETER TEMPERATURE TOO HIGH ERROR WAS DISPLAYED ON THE NGEN MONITOR (CUT-OFF WAS NOT EXCEEDED). THIS PREVENTED THE SYSTEM FROM COMING ON ABLATION AND LED THEM TO CHECKING IF IRRIGATION WAS WORKING, EVEN THOUGH THE PUMP DISPLAYED LOW FLOW OF 2 ML AND WAS RUNNING. TEMPERATURE SETTINGS WERE SET PROPERLY ON THE MONITOR FOR ABLATION. THE CATHETER WAS REMOVED FROM THE BODY TO CHECK IRRIGATION FLOW. THEY CHECKED THE CATHETER TIP FOR OCCLUSION IN THE IRRIGATION HOLES OF THE CATHETER AND DID NOT FIND ANYTHING. THEY TRIED TO HIGH FLOW FLUSH AND THERE WAS NO RESPONSE OF FLUID THROUGH THE CATHETER, JUST PRESSURE BUILDUP IN THE TUBING AT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449980 ↗
• InjuryJan 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS. DURING ABLATION, THERE WERE TWO STEAM POPS DURING THE PROCEDURE WHEN PERFORMING ABLATION ON THE LEFT SIDE. THERE WERE NO IMPEDANCE SPIKES DISPLAYED ON THE CARTO 3 SYSTEM. THE PROCEDURE CONTINUED WITHOUT TROUBLESHOOTING. PERICARDIAL EFFUSION WAS NOTICED ON THE RIGHT SIDE OF THE HEART CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) DURING A POST-CHECK ON THE PATIENT AFTER THE PROCEDURE WAS COMPLETED. THE PATIENT HAD NO VISIBLE SYMPTOMS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED. TRANSSEPTAL WAS PERFORMED WITH BAYLIS MACHINE AND VERSACROSS SHEATH, UNKNOWN SERIAL NUMBER. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS PATIENT CONDITION. THE PATIENT OUTCOME IS FULLY RECOVERED. CORRECT SETTINGS ON DEVICES AND NO ERROR MESSAGES DURING THE PROCEDURE. THE PATIENT STAYED OVERNIGHT.

  Patient problems: Cardiac Tamponade

  MAUDE report 18523168 ↗
• InjuryNov 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS OF ABOUT 200 CC OF FLUID, APPLICATION OF A DRAIN LEFT IN OVERNIGHT AND HOSPITALIZATION. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS USED FOR GOING TRANSSEPTAL. ABLATION WAS PERFORMED AND IT WAS DISCOVERED AND CONFIRMED A PERICARDIAL EFFUSION WITH TEE. THE PROCEDURE WAS ABORTED. NO EVIDENCE OF STEAM POP. THE PATIENT HAD NO VISIBLE SYMPTOM AND FULLY RECOVERED. PHYSICIAN'S OPINION OF THE CAUSE IS PATIENT CONDITION AND MUST HAVE BEEN PUSHING TOO HARD WITH DECANAV WHILE MAPPING." CORRECT SETTINGS ON DEVICES AND NO ERROR MESSAGES ON EQUIPMENT.

  Patient problems: Cardiac Tamponade

  MAUDE report 18212864 ↗
• InjuryOct 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. POST PROCEDURE, THE PATIENT EXPERIENCED FACIAL DROOP. A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED TO RULE OUT STROKE AND WAS INCONCLUSIVE. THE PATIENT WAS STABLE.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 18026496 ↗
• InjuryAug 2, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AFIB ¿ PAROXYSMAL ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER (STSF). THE PATIENT SUFFERED CARDIAC PERFORATION REQUIRING A SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT THERE WAS AN ISSUE WITH THE ABLATION CATHETER (FORCE VECTOR). THE PHYSICIAN STATED THAT THE VECTOR WAS NOT "COOPERATING WITH HIM" LIKE USUAL. HE DID NOT LIKE THE WAY THE VECTOR WAS PROJECTED. THE CATHETER CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, AND THE ISSUE WAS NOT RESOLVED. THEY CONTINUED THE USE OF THE SECOND CATHETER FOR THE CASE, AND THE ABLATION WAS SUCCESSFUL AS MEASURED BY VOLTAGE MAP AND PACING MANEUVERS. THEY DID NOT HAVE FURTHER DETAILS REGARDING THIS ISSUE AT THE TIME OF THE CALL. IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION (PE). AFTER TRANSSEPTAL ACCESS WAS LOST, WHEN ATTEMPTING TO GO BACK TRANSSEPTAL, THE PHYSICIAN BELIEVES THE ABLATION CATHETER THEN CAUSED A PERFORATION. THE EFFUSION WAS DISCOVERED AFTER ABLATION DURING A POST-CASE ROUTINE INTRACARDIAC ECHCARDIOGRAPHY (ICE) SCAN. A PER

  Patient problems: Cardiac Perforation

  MAUDE report 17445136 ↗
• InjuryAug 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS A REPORTED THAT A PATIENT UNDERWENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE THAT INCLUDED THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED SURGICAL INTERVENTION. AN ADVERSE EVENT WAS REPORTED. TOWARD THE END OF THE PROCEDURE WHEN DOING A CTI LINE, THERE WAS A PERICARDIAL EFFUSION THAT OCCURRED. THE PATIENT'S BLOOD PRESSURE DROPPED. THE CALLER COULD NOT PROVIDE SPECIFIC VITAL DATA. THEY NOTICED AND CONFIRMED A PERICARDIAL EFFUSION WAS PRESENT ON ICE IMAGES. THE SOUNDSTAR CATHETER WAS UTILIZED TO CONFIRM THE EFFUSION. THE PERICARDIOCENTESIS WAS PERFORMED AND THEY "REMOVED ROUGHLY 11,000 UNITS" OF FLUIDS. THE PATIENT WAS TRANSPORTED TO THE OPERATING ROOM FOR SURGERY AND THE CALLER BELIEVES THE PATIENT IS STABLE. THE PHYSICIAN BELIEVES THAT A PERFORATION OCCURRED DURING THEIR CTI LINE ABLATION PHASE. THEY USED THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER, SOUNDSTAR CATHETER, PENTARAY CATHETER, AND THE ESOPHASTAR CATHETER DURING THE PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Perforation

  MAUDE report 17435417 ↗
• InjuryJul 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA - LEFT (L-ISVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND A PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE. THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED BY THE PHYSICIAN. A TRANSEPTAL PUNCTURE WAS PERFORMED AND A PREFACE SHEATH (CATALOG AND LOT NUMBER UNKNOWN BY THE CALLER) WAS INSERTED INTO THE LEFT ATRIUM. THE BWI DECA NAV (CATALOG: R7D282CT, LOT:31035492M) WAS INSERTED INTO THE LEFT VENTRICLE VIA THE TRANSEPTAL SHEATH. THE MAPPING WAS PERFORMED WITH THE DECA NAV CATHETER. THE DECA NAV WAS THEN REMOVED AND THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER WAS INSERTED INTO THE LEFT VENTRICLE. THEY WERE UNABLE TO PACE FROM THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER SO THEY PULLED THE CATHETER BACK INTO THE LEFT ATRIUM TO TEST PACING CAPABILITIES. THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER WAS ADVANCED BACK INTO THE LEFT VENTRICLE. THE PHYSICIAN THEN PERFORMED RADIO FREQUENCY ABLATIO

  Patient problems: Cardiac Tamponade

  MAUDE report 17309231 ↗
• MalfunctionJun 29, 2023Electrical Shorting; Electrical Shorting

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CADIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE ABLATION PROCESS, THE ERROR OF CURRENT LEAKAGE CAME FOR 3 TIMES. THEN WE DECIDED TO CHANGE THE ABLATION CABLE BUT THE ERROR REMAINED. WE CHANGED THE ABLATION CATHETER WHICH WAS THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THEN THE ERROR HAS BEEN GONE. THEREFORE THE CATHETER WAS DEFECT. THE "CURRENT LEAKAGE ERROR" WAS DISPLAYED BECAUSE OF SIGNAL NOISE AND ALSO AFTER THAT SIGNAL LOSS ISSUE BECAUSE THIS ERROR CAME 3 TO 4 TIMES. THIS SIGNAL INTERFERENCE SHOWED UP ON ALL ECG (BS+ IC) CHANNELS. IT WAS OBSERVED ON BOTH DEVICES (CARTO & RECORDING SYSTEM AS WELL). THEIR MONITORING SYSTEMS WERE WORKING WELL, THE ONLY ISSUE WAS ON RECORDING SYSTEM. THE AFFECTED CATHETER WAS IN THE PATIENT¿S BODY AT THE TIME OF INCIDENT BUT THERE WERE NO CIRCUMSTANCES ON THE PATIENT. THE CATHETER WAS CHANGED SO FAST AND THEN EVERYTHING WORKED WELL AGAIN. THE CUSTOMER¿S REPORTED ISSUES ARE NOT CONSIDERED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17223652 ↗
• InjuryMay 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING AN ATYPICAL ATRIAL FLUTTER PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED ON THE ICE CATHETER AFTER GOING TRANSEPTAL. A PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN. THE PATIENT WAS STABLE AT THE TIME OF THE CALL. NO OTHER DETAILS WERE AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PATIENT CONDITION. OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED. THE EVENT HAPPENED DURING THE PHYSICIAN¿S NORMAL AND PREFERRED METHOD OF TRANSSEPTAL PUNCTURE. NO ABLATION WAS PERFORMED PRIOR TO THE EVENT. NO EVIDENCE OF STEAM POP; NO ABLATION PERFORMED. THE EVENT OCCURRED DURING THE TRANSSEPTAL PHASE. THE FLOW SETTING FOR THE IRRIGATED CATHETER WAS AT 2 ML/MIN PER STSF IFU. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ERROR MESSAGES; NO HIGH CONTACT ERROR, NO ERRORS WHATSOEVER. GRAPH, DASHBOARD, VISITAG WERE SELECTED, HOWEVER NO ABLATION EVER TOOK

  Patient problems: Cardiac Tamponade

  MAUDE report 17000229 ↗
• InjuryMay 17, 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 UNI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT AFTER AN AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED AS THEY WERE PERFORMING A POST PROCEDURE CHECK USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THEY STATED THE PHYSICIAN NOTICED SOME EFFUSION BUT THE PATIENT'S BLOOD PRESSURE WAS STABLE SO THEY DECIDED TO CLOSE. ABOUT AN HOUR LATER THEY NOTICED THE PATIENT BLOOD PRESSURE DECREASED SO THEY DECIDED TO DO A STAT TRANSTHORACIC ECHOCARDIOGRAM (TTE) TO CONFIRM THE PERICARDIAL EFFUSION. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 550ML OF FLUID WERE REMOVED. THE PHYSICIAN WAS UNABLE TO ASPIRATE ANY FURTHER, SO THE PHYSICIAN DID NOT BELIEVE THE PERICARDIAL EFFUSION WAS ACTIVE ANYMORE. THEY CONFIRMED THE PATIENT'S BLOOD PRESSURE REMAINED STABLE DURING THIS TIME. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN BELIEVED THE PERICARDIAL EFFUSION OCCURRED DURING THE CAVOTRICUSPID ISHMUS (CTI) ABLATION. THE ADVERSE EVENT WAS DI

  Patient problems: Cardiac Tamponade

  MAUDE report 16947407 ↗
• InjuryJan 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING A LEFT-SIDED ATRIAL FLUTTER CASE, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. THEY REPORTED THAT A STEAM POP WAS NOTICED IN THE PATIENT, INITIALLY IN THE DISTAL LEFT ATRIAL APPENDAGE. THE PERICARDIAL EFFUSION WAS DISCOVERED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE), AND THE PATIENT'S BLOOD PRESSURE THEN DROPPED. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS, AND ABOUT 355CC OF FLUID WAS ASPIRATED FROM THE PATIENT. THE PATIENT IS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS, DURING THE ABLATION PHASE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS REPORTED AS A BWI PRODUCT MALFUNCTION. INTERVENTION INCLUDED PERICARDIOCENTESIS AND BLOOD WAS GIVEN. THE OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS FULLY RECOVERED. PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE E

  Patient problems: Cardiac Tamponade

  MAUDE report 16153979 ↗
• MalfunctionOct 18, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION 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 PHYSICIAN WAS WIPING OFF THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER, IT WAS NOTICED THAT THERE WAS BLOOD INSIDE THE CHAMBER OF THE FORCE SENSOR. THE CALLER REPORTED THAT THE PHYSICIAN TRIED TO CLEAN THE A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER, AND SOME OF THE BLOOD HAD DRAINED OUT, BUT THERE WAS STILL SOME BLOOD INSIDE THE FORCE SENSOR CHAMBER. THE SMARTTOUCH SF CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. IT WAS REPORTED THERE WAS NO DIFFICULTY IN MANEUVERING THE CATHETER AND THERE WAS NO PHYSICAL DAMAGE SEE. THE CUSTOMER¿S REPORTED ISSUE OF BLOOD INSIDE THE CHAMBER OF THE FORCE SENSOR (PEBAX) IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON (B)(6) 2022, THE BWI PAL REVEALED THAT A V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629812 ↗
• InjuryOct 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD FEMALE PATIENT (170 LBS) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT THE DEVICE WAS BURNING ON THE ROOF AND PHYSICIAN FELT A POP. AFTERWARDS A PERICARDIAL EFFUSION STARTED FORMING AND THEN IMMEDIATELY THEY PERFORMED A PERICARDIOCENTESIS. THE PHYSICIAN DIDN¿T SPECIFY ON WHAT THEIR OPINION WAS REGARDING THE CAUSE OF THIS ADVERSE EVENT BUT DID NOT BLAME THE CATHETER. THERE WERE NO PRODUCT ISSUES BEFORE THE ADVERSE EVENT. PATIENT WAS STABLE AFTER PERICARDIAL EFFUSION. THE PATIENTS¿ SYMPTOMS IMPROVED. PATIENT WAS SENT TO A RECOVERY UNIT POST CASE - UNSURE HOW LONG DURATION OF STAY. A SMARTABLATE GENERATOR WAS USED IN THE EVENT WITH THE CORRECT CATHETER SETTINGS SELECTED ON THE SMARTABLATE GENERATOR. THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. A BAYLIS NEEDLE WAS USED FOR TRANSSEPTAL PUNCTURE. THE EVENT OCCURRED DURING THE ABLATION PHASE. AN IRRIGATED CATHETER WAS USED IN THE EVENT, THE FLOW SETTING WAS HIGH 15NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEB

  Patient problems: Cardiac Tamponade

  MAUDE report 15524210 ↗
• InjurySep 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 67-YEAR-OLD FEMALE PATIENT (54KG) UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION (STSF) CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS, SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. THE PATIENT SUFFERED A CARDIAC TAMPONADE DURING THE PROCEDURE. THE PHYSICIAN NOTED THAT THE PATIENT HAD ROTATED CARDIAC ANATOMY AND SEVERE SCOLIOSIS, WHICH MADE IT DIFFICULT TO PLACE THE SOUNDSTAR CATHETER AND OBTAIN DISCERNIBLE ULTRASOUND IMAGES. TWO TRANSSEPTAL PUNCTURES WERE MADE, THE SECOND MORE DIFFICULT (HIGHER) THAN THE FIRST, BUT THE PHYSICIAN WAS ABLE TO PLACE CATHETERS IN THE LEFT ATRIUM. WHEN BEGINNING TO MAP, IT WAS DISCOVERED THAT THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) HAD BEEN ADMINISTERING VASOPRESSOR MEDICATION TO TREAT THE DECREASING BLOOD PRESSURE. THE PHYSICIAN MANIPULATED THE SOUNDSTAR CATHETER TO REVEAL THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, REMOVING 950 ML OF BLOOD. THE PATIENT STABILIZED AND BEFORE REMOVING THE STSF CATHETER THE PHYSICIAN BURNED A FLUTTER LINE IN THE RIGHT ATRIUM. THE PROCEDURE WAS COMPLETED, AND T

  Patient problems: Cardiac Tamponade

  MAUDE report 15367946 ↗
• MalfunctionSep 2, 2022Material Puncture/Hole; Insufficient Device Problem Information; Material Puncture/Hole; Insufficient Device Problem Information

  BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER WHICH WAS IDENTIFIED TO HAVE A HOLE IN THE PEBAX. UPON RECEIVING THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER, VISUAL INSPECTION IDENTIFIED ¿A HOLE IN THE PEBAX¿ WHICH IS CONSIDERED AN MDR REPORTABLE MALFUNCTION. THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER WAS RETURNED LABELED WITH A COMPLAINT NUMBER FOR WHICH PRODUCT DETAILS, SUCH AS THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER DO NOT MATCH. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION FOR THE WRONG PRODUCT RECEIVED, HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. A NEW COMPLAINT WAS CREATED TO INVESTIGATE AND REPORT THE MALFUNCTION FOUND ALTHOUGH NO SPECIFIC EVENT DETAILS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15343578 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031. 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-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-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-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