ThermoCool SmartTouch D132704Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10846835009194), received between Jun 14, 2016 and Apr 29, 2025 — classified as 7 deaths, 81 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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 FOUND A HOLE ON THE PEBAX'S SURFACE. FORCE SENSOR BROKEN. THE TOUCH MODULE ALWAYS SHOWED HI AFTER ZEROING SEVERAL TIMES. CLOSED AND REOPENED THE STUDY. REMOVED CATHETER AND REINSERTED INTO CARDIAC CHAMBER WITHOUT RESOLUTION. CABLE CHANGED. THE ONLY SOLUTION WAS TO CHANGE THE CATHETER. NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 03-APR-2025 OBSERVED FOREIGN MATERIAL PRESUMABLY BLOOD INSIDE THE PEBAX. ADDITIONALLY, UNDER MICROSCOPE INSPECTION, FOUND A HOLE ON THE PEBAX'S SURFACE. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A HOLE ON THE PEBAX'S SURFACE ON 03-APR-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930219 ↗
• InjuryOct 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER, AND THE PATIENT EXPERIENCED HEART BLOCK THAT REQUIRED ICD (IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR) IMPLANTATION. WHEN ABLATING THE LEFT VENTRICULAR ANTERIOR FASCICLE, THE PATIENT DEVELOPED COMPLETE HEART BLOCK. THIS WAS OBSERVED ON CARTO 3 SYSTEM AND ELECTROPHYSIOLOGY RECORDING SYSTEMS ELECTROCARDIOGRAM DISPLAYS. THEY IMMEDIATELY PACED WITH THE RIGHT VENTRICULAR CATHETER ALREADY IN THE HEART. THE PATIENT RECEIVED AN ICD IMPLANTATION AS A RESULT OF THE HEART BLOCK. PATIENT FULLY RECOVERED AND CONDUCTION CAME BACK. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PROCEDURE. THE INTERVENTION PROVIDED WAS A BI V (BI-VENTRICULAR) ICD IMPLANT.

  Patient problems: Heart Block

  MAUDE report 20464875 ↗
• InjuryMay 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND DURING ABLATION, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS, SURGICAL INTERVENTION, AND PROLONGED HOSPITALIZATION. DURING AN AFIB CASE, THERE WAS A DROP IN BLOOD PRESSURE IN THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY THE ULTRASOUND MACHINE AND CONTRAST FLUOROSCOPY WAS DONE TO SEE WHERE THE CONTRAST WAS COMING OUT FROM. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS TRANSPORTED TO THE HOSPITAL. ONCE THE PATIENT WAS TRANSPORTED TO THE HOSPITAL, HIS CHEST WAS OPENED TO SEE WHERE THE BLEEDING WAS COMING FROM. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. A TRANSEPTAL PUNCTURE WAS PERFORMED, AND ABLATION WAS PERFORMED PRIOR TO THE TRANSEPTAL. THE PHYSICIAN MADE NO NOTE OF A STEAM POP OCCURRING. NO ERROR MESSAGES WERE OBSERVED ON THE BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 19273790 ↗
• MalfunctionApr 29, 2024Electrical Shorting; Appropriate Device Problem Term/Code Not Available; Unintended Electrical Shock; Electrical Shorting; Appropriate Device Problem Term/Code Not Available; Unintended Electrical Shock

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION WHICH INCLUDED A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A CARTO® 3 SYSTEM AND THE PATIENT EXPERIENCED ELECTRICAL SHOCK. IT WAS REPORTED THAT THE PATIENT GOT ELECTROCUTED RIGHT WHEN THE PHYSICIAN WAS ABOUT TO PUT THE CATHETER IN THE GROIN. THE PHYSICIAN STATED THAT THERE WAS WATER ON THE GROIN. THE PATIENT SCREAMED AFTER RECEIVING THE ELECTRIC SHOCK AND A CURRENT LEAKAGE ERROR 7 APPEARED ON THE CARTO 3 SYSTEM. THE PATIENT STATED THAT THERE WAS A SHOCK IN HER LEG. THE CATHETER WAS NOT FULLY CONNECTED TO THE HANDLE OF THE CATHETER. THE PHYSICIAN PULLED THE CATHETER BACK AND GAVE THE PATIENT A CHANCE TO RECOVER. THE LAST KNOWN PATIENT STATUS WAS THAT THE PATIENT WAS STABLE AND AWAKE. THE PROCEDURE CONTINUED. THE ACCOUNT WAS ADVISED TO STOP USING THE CARTO 3 SYSTEM. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN BELIEVED THAT IT WAS DUE TO HIS FELLOW CONNECTING THE CATHETER INCORRECTLY. THE CABLE WAS NOT COMPLETELY SEATED INTO THE HANDLE OF THE CATHETER AT THE TIME OF THE EVENT. THERE WAS AN OPTRELL AND SOUNDSTAR IN THE BODY. HOWEVER, THE EVENT OCCURRED J

  Patient problems: Electric Shock

  MAUDE report 19206926 ↗
• MalfunctionJan 28, 2024Positioning Failure; Entrapment of Device; Material Twisted/Bent; Positioning Failure; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THE CATHETER IT GOT STUCK IN THE AORTA. WHEN BRINGING UP THE ST VIA THE ARTERY TO THE AORTA, IT WAS NOT ABLE TO BEND THE CATHETER AS USUAL. BECAUSE OF THE UNUSUAL MANIPULATION OF THE CATHETER IT GOT STUCK IN THE AORTA. THE CATHETER HAD SUCH A BAD CURVE RESULTING IT NEEDED TO GET OUT BY USING SPECIALIZED EQUIPMENT. EVEN THROUGH MANIPULATION OR NOT IT SHOULD NOT BE ABLE TO BEND LIKE THAT. THERE WAS NO PATIENT CONSEQUENCE. A NEW CATHETER WAS USED AND ISSUE WAS SOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18593130 ↗
• MalfunctionJan 16, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER HAD PACKAGING SMASHED AND DAMAGED UPON ARRIVAL. IT WAS REPORTED THAT THE TOP OF THE WHITE CATHETER BOX WAS DAMAGED AND SMASHED UPON ARRIVAL. THE CALLER STATED THAT THE CATHETER WAS NOT USABLE. THE CALLER STATED THAT THERE WAS SOME INTERRUPTION IN THE CATHETER'S STERILE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18523161 ↗
• MalfunctionNov 7, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. INITIALLY, IT WAS REPORTED THAT DURING ABLATION, THE FORCE READING ON THE CATHETER WENT FROM 10G TO HIGH. THE FORCE READING RETURNED FROM HIGH TO 10G FORCE READING WHEN THEY CAME OFF ABLATION. THEY CHANGED THE INTERFACE CABLE, BUT THIS DID NOT RECTIFY THE ISSUE. WHEN THE ABLATION CATHETER WAS CHANGED, THE ISSUE WAS RESOLVED, AND THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE FORCE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 12-OCT-2023, A HOLE AND REDDISH MATERIAL WAS FOUND. THE HOLE IN THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 12-OCT-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085032 ↗
• MalfunctionFeb 10, 2023Insufficient Cooling; Communication or Transmission Problem; Insufficient Cooling; Communication or Transmission Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THERE WERE TEMPERATURE SPIKES AND NO ECG SIGNALS ON ALL CHANNELS WERE OBSERVED. BROKEN SENSOR WAS REPORTED. WHEN CONNECTED, ALL THE SIGNALS DISAPPEARED AND NOTHING WAS WORKING. TEMPERATURE SPIKES UP TO 65°C WAS RECORDED ON THE SMARTABLATE RF GEN. THERE WAS NO SURGICAL DELAY. USERS ATTEMPTED TO RESOLVE BY CHANGING CABLE AND THEN CHANGING CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED FROM THE EVENT. THERE WAS NO PATIENT CONSEQUENCE. THE SIGNAL LOSS WAS OBSERVED ON ALL CHANNELS AND LOST ON BOTH CARTO AND RECORDING SYSTEM. DURING THE SIGNAL LOSS, THE AFFECTED CATHETER WAS NOT INSIDE THE PATIENT¿S BODY. TEMPERATURE SPIKES OCCURRED AS SOON AS THE CATHETER WAS CONNECTED. BESIDES TEMPERATURE SENSOR, MAPPING CATHETER SENSOR ERROR HAPPENED AS SOON AS THE CATHETER WAS CONNECTED. THE HIGH TEMPERATURE ISSUE IS MDR REPORTABLE. THE ISSUE OF NO ECG SIGNALS ON ALL CHANNELS IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16357946 ↗
• InjuryMar 15, 2022High Readings; Patient Device Interaction Problem; High Readings; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. THE PATIENT HAD A CARDIAC TAMPONADE THAT WAS NOTICED DURING THE MAPPING PHASE WHEN THERE WAS A DROP IN THE PATIENT'S BLOOD PRESSURE. THE TAMPONADE WAS CONFIRMED VIA AN INTRACARDIAC ECHOCARDIOGRAM. THE PATIENT HAD A PERICARDIOCENTESIS AND 1300ML OF FLUID WERE REMOVED. THE PATIENT DID NOT REQUIRE ANY SURGICAL REPAIR AND IS STABLE AS OF THE TIME OF THE CALL AND IS BEING KEPT FOR OBSERVATION OVERNIGHT. THE PHYSICIAN THOUGHT THE TAMPONADE OCCURRED OVER TIME THROUGHOUT THE COURSE OF THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE RELATED. THE PATIENT OUTCOME WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). A TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. ABLATION WAS NOT PERFORMED PRIOR TO THE CARDIAC TAMPONADE. THERE WAS A HIGH FORCE ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. FORCE VISUALIZATION USED WAS GRAPH, DASHBOARD & VECTOR. SIN

  Patient problems: Cardiac Tamponade

  MAUDE report 13775292 ↗
• InjuryMar 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN UNKNOWN FEMALE PATIENT UNDERWENT ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION. NEAR THE END OF THE CASE THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS USED TO CONFIRM A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED EXTRACTING ABOUT 1100CC OF FLUID. A DRAIN WAS PLACED FOR OVERNIGHT. PATIENT WAS STABLE. PROCEDURE WAS ABORTED. THEY WERE USING AN AVERAGE OF 40 WATTS IN THE LEFT VENTRICLE. THE PHYSICIAN THOUGHT THE QUAD CATHETER IN THE RIGHT VENTRICLE MIGHT HAVE CAUSED A PERFORATION. NO FURTHER INTERVENTION WAS EXPECTED. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS IMPROVED. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT AS DRAIN WAS PLACED OVERNIGHT. GENERATOR INFORMATION: SN: (B)(4) AND REF M490003. THERE WAS NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED POST ABLATION. AN IRRIGATED CATHETER WAS USED IN THE EVENT, THE FLOW SETTING WAS 17 CC. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PU

  Patient problems: Cardiac Tamponade

  MAUDE report 13754360 ↗
• DeathFeb 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA - LEFT (ISVT- LEFT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED VENTRICULAR FIBRILLATION (VFIB) REQUIRING CPR, DEFIBRILLATION, MEDICATIONS. THE PATIENT EXPIRED. DURING THE PROCEDURE, THE TEAM MAPPED AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) ON THE LEFT VENTRICLE (LV) AND MADE 3 RADIOFREQUENCY (RF) APPLICATIONS ON SITE OF INTEREST (WITHIN NORMAL PARAMETERS). BEFORE FINISHING LAST APPLICATION, PATIENT DEVELOPED VFIB. PHYSICIANS TRIED TO DEFIBRILLATE ON MANY OCCASIONS AND REVERT IT WITH DRUGS, WITHOUT SUCCESS. AFTER 30MIN OF CARDIOPULMONARY RESUSCITATION (CPR), THE PATIENT DIED. THERE WAS NO PRESENCE OF PERICARDIAL EFFUSION ON ECHOCARDIOGRAPHY (ECHO). THE PROCEDURE WAS NOT COMPLETED. ADDITIONAL INFORMATION RECEIVED ON 7-FEB-2022. THE DATE OF DEATH WAS (B)(6) 2022. THE PHYSICIAN¿S OPINION ON THE CAUSE OF DEATH IS THAT IT IS PATIENT CONDITION RELATED (VENTRICULAR ELECTRICAL STORM (VES)). THE FORCE VISUALIZATION FEATURES USED WERE GRAPH, DASHBOARD, VECTOR & VISITAG WITH THE VISITAG MODULE PARAMETERS FOR STABILITY SET TO MAXIMUM DISTANCE CHANGE 3

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 13610781 ↗
• InjuryDec 12, 2021Patient 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¿ BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 600ML OF FLUID WERE REMOVED AND THEY PUT A DRAIN IN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN STATED THAT THE PATIENT ALREADY HAD A BAD HEART, AND HIS PUMPING FUNCTION WAS REALLY LOW AT AROUND 20 % AND HAD OTHER HEALTH ISSUE. THIS EVENT OCCURRED DURING THE PVI CASE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PATIENT¿S CONDITION. FLUID DRAINED FROM THE EFFUSION. PATIENT SENT TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION OVERNIGHT. PATIENT OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). IT IS UNKNOWN IF HE REQUIRED EXTENDED HOSPITALIZATION. THE PATIENT WAS ALREADY SCHEDULED TO STAY THE NIGHT IN THE HOSPITAL; HOWEVER, THE PATIENT REQUIRED ICU OBSERVATIO

  Patient problems: Cardiac Tamponade

  MAUDE report 12981889 ↗
• MalfunctionOct 28, 2021High Readings; Contamination /Decontamination Problem; High Readings; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB OBSERVED A CUT ON THE PEBAX WITH REDDISH-BROWN MATERIAL INSIDE. INITIALLY. IT WAS REPORTED THAT DURING ABLATION, FORCE READINGS ON THE CATHETER WENT UP TO 70 GRAMS. THERE WAS NO IMPEDANCE RISE WHEN THIS HAPPENED. THE CABLE WAS EXCHANGED, AND THE ISSUE PERSISTED. THE CATHETER WAS EXCHANGED, AND THE ISSUE WAS RESOLVED AND THE CASE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. THERE WAS NO PATIENT CONSEQUENCE. THE HIGH FORCE ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE ISSUE WAS HIGHLY DETECTABLE WHEN OCCURRING. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS LOW. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND THAT THERE WAS A CUT ON THE PEBAX WITH REDDISH-BROWN MATERIAL INSIDE AND INTERNAL PARTS EXPOSED. THE ISSUE WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 4-OCT-2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12710116 ↗
• InjuryOct 14, 2021Patient 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¿ BI-DIRECTIONAL NAVIGATION CATHETER (STSF) AND SUFFERED CARDIAC TAMPONADE (CT) REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, AFTER THE LEFT ATRIUM ABLATIONS WERE DONE, AND BEFORE THE CAVOTRICUSPID ISTHMUS (CTI) LINE WAS BURNED, A PERICARDIAL EFFUSION WAS NOTICED. THE PATIENT'S BLOOD PRESSURE DROPPED SLIGHTLY. WHEN SWEEPING THE INTRACARDIAC ECHOCARDIOGRAM (ICE) BY TO GET A VIEW OF THE CTI TO GO TO THE RIGHT SIDE, THE PERICARDIAL EFFUSION WAS CONFIRMED. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND AN UNKNOWN AMOUNT OF FLUID WERE REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN BELIEVED THAT THE PATIENT¿S ATRIUM WAS JUST VERY UNHEALTHY AND EXTENSIVE ABLATION NECESSARY IN THE LEFT ATRIUM WAS THE CAUSE. THE PATIENT¿S CONDITION WAS REPORTED TO HAVE IMPROVED. AT THE TIME OF REPORTING, THE PATIENT WAS MOSTLY RECOVERED. ABOUT 260CC'S WERE REMOVED DURING THE PERICARDIOCENTESIS AND THEN A SLOW DRAIN WAS LEFT IN, WHICH WAS ABLE TO BE REMOVED THE FOLLOWING MORNING. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. TRA

  Patient problems: Cardiac Tamponade

  MAUDE report 12637296 ↗
• DeathSep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT ((B)(6) KG, 176CM) UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT-LEFT) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, SURGICAL INTERVENTION AND DEATH. THE DOCTOR WAS PERFORMING THE LATERAL WALL ABLATION OF THE LEFT VENTRICLE, DURING THE ABLATION HE NOTICED THAT THE CAVITY WAS PERFORATED BY THE CATHETER. THEREFORE, THEY DID A PERICARDIAL DRAINAGE TO STOP THE BLEEDING. FEW SECONDS LATER IT BLED AGAIN SO THEY DECIDED TO PERFORM AN OPEN CHEST CARDIAC SURGERY WHERE THEY SAW THAT THE MAIN BLEEDING FOCUS WAS THE LACERATION OF THE SUBCLAVIAN VEIN WHERE THE ANESTHESIOLOGIST INSERTED THE CENTRAL CATHETER THROUGH THAT VEIN. THE PATIENT DIED BECAUSE THEY COULD NOT STOP THAT BLEEDING. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE PATIENT HAD AN IMPLANTABLE CARDIAC DEFIBRILLATOR AND A PREVIOUS ABLATION OF ISCHEMIC VENTRICULAR TACHYCARDIA IN 2012 DUE TO AN ACUTE MYOCARDIAL INFARCTION. ON 3-SEP-2021, ADDITIONAL INFORMATION WAS LATER RECEIVED WHICH INDICATED THE ADVERSE EVENT

  Patient problems: Cardiac Tamponade

  MAUDE report 12538212 ↗
• InjuryMar 30, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT SUFFERED A VASCULAR INJURY. WHILE DOING A LEFT OUTFLOW TRACK CASE WITH THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER, THE PHYSICIAN (FELLOW) DECIDED THEY WANTED TO BURN ON THE RIGHT-SIDE OUTFLOW TRACT AND THE CATHETER WAS MOVED FROM THE LEFT SIDE TO THE RIGHT SIDE. IN DOING SO, THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS ACCIDENTALLY CONTAMINATED AND REPLACED. THE NEW CATHETER WAS THEN ADVANCED INTO THE EXISTING ACCESS ON THE RIGHT FEMORAL VEIN AND THE CATHETER WAS MEETING RESISTANCE. IT WAS VERIFIED UNDER FLUOROSCOPY THAT THE CATHETER WAS NO LONGER IN THE LUMEN OF THE VEIN. THE ATTENDING PHYSICIAN WAS MADE AWARE AND VASCULAR SURGERY WAS NOTIFIED. THE CATHETER WAS REMOVED SAFELY, AND THE PATIENT WAS IN STABLE CONDITION. THE PATIENT WAS STABLE DURING THE ENTIRE PROCEDURE. THE CASE WAS ABORTED. THE ATTENDING FELT IT WAS USER ERROR OF THE CATHETER INSERTION THAT WAS THE ROOT CAUSE OF THE ISSUE. THE PATIENT WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 11593752 ↗
• MalfunctionMar 11, 2021Material Puncture/Hole; Device Contamination with Body Fluid; Material Puncture/Hole; Device Contamination with Body Fluid

  A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AFTER THE PHYSICIAN REMOVED THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER FROM THE BODY, IT WAS NOTICED THAT THERE WAS CHAR ON THE TIP OF THE CATHETER. THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS REPLACED WITH A ANOTHER THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED ISSUE OF CHAR WAS ASSESSED AS NOT MDR REPORTABLE. CHAR IS A PHYSICAL PHENOMENON OF RADIO FREQUENCY ENERGY DELIVERY AND CAN BE THE NORMAL RESULT OF THE ABLATION PROCESS. THE PRESENCE OF CHAR ON THE ELECTRODES DOES NOT REPRESENT A SERIOUS INJURY IN ITSELF, NOR IS IT NECESSARILY THE RESULT OF DEVICE MALFUNCTION. ON 1/29/2021, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. ON 2/11/2021, THE COMPLAINT CATHETER WAS INSPECTED AND IT WAS FOUND WITH A REDDISH MATERIAL INSIDE THE PEBAX. THE PEBAX WAS INSPECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467878 ↗
• MalfunctionJan 12, 2021Material Puncture/Hole; Failure to Sense; Material Puncture/Hole; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA PROCEDURE WITH A THERMOCOOL(R) SMART TOUCH" BI-DIRECTIONAL NAVIGATION CATHETER AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB OBSERVED A HOLE ON THE PEBAX. INITIALLY IT WAS REPORTED THAT THE CARTO 3 SYSTEM WAS DISPLAYING A FORCE SENSOR ERROR 106 WHEN COMING ON ABLATION. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. IT WAS REPORTED THAT THE CARTO 3 SYSTEM WAS OPERATING PER SPECIFICATIONS AND WAS NOT RESPONSIBLE FOR THE PRODUCT ISSUE. IN ADDITION, IT WAS REPORTED THAT THE CATHETER HAD BEEN DETERMINED TO BE THE ROOT CAUSE OF THE COMPLAINT REPORTED. THE PROCEDURE WAS CONTINUED. THE FORCE SENSOR ERROR 106 WAS ASSESSED AS NOT MDR REPORTABLE AS THE WARNING FUNCTIONED AS INTENDED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND OBSERVED ON (B)(4) 2020 REDDISH MATERIAL INSIDE THE PEBAX AND A HOLE ON IT. THE HOLE ON THE PEBAX WAS ASSESSED AS A MDR REPORTABLE ISSUE. THE AWARENESS DATE FOR THIS FINDING IS 12/15/2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153245 ↗
• MalfunctionDec 28, 2020Insufficient Cooling; Device Contamination with Body Fluid; Patient Device Interaction Problem; Insufficient Cooling; Device Contamination with Body Fluid; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WHERE COAGULUM OCCURRED. IT WAS REPORTED THAT COAGULUM FORMED ON THE TIP OF THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AFTER ABOUT AN HOUR OF ABLATING. THERE WAS A SUDDEN TEMPERATURE RISE OF 40 DEGREES. IT WAS AT THIS POINT THAT THE CATHETER WAS REMOVED FROM THE PATIENT AND THE CHAR WAS NOTED. THE CATHETER WAS EXCHANGED TO PROCEED WITH THE CASE SUCCESSFULLY, WITHOUT PATIENT HARM. APPROPRIATE IRRIGATION SETTINGS FOR THE POWER SETTINGS ON THE GENERATOR/PUMP WERE CONFIRMED. THERE WAS NO PATIENT CONSEQUENCE. THERE WERE NO FLOW-RELATED ISSUES. THE GENERATOR WAS IN POWER CONTROL MODE 40W DEFAULT CUT OFFS. THE PATIENT WAS ANTICOAGULATED AND ACT GREATER THAN 350SEC WAS MAINTAINED. HEPARINIZED NORMAL SALINE WAS USED. THERE WERE NO LESIONS OVER 60SEC. THE AVERAGE CONTACT FORCE WAS NOT GREATER THAN 40 GRAMS., IT WAS INTERMITTENTLY GREATER THEN 25GR. THE VISITAG SETTINGS WERE RESPIRATION SETTING, STABILITY RANGE, STABILITY TIME, FORCE OVER TIME, & TAG SIZE. RESPIRATION GATED, RANGE: 2 MM, TIME: 3 SEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11084234 ↗
• MalfunctionNov 13, 2020High impedance; Device Sensing Problem

  THE ABLATION CATHETER WAS PLACED IN THE BODY. THE CATHETER WAS DEFECTIVE DUE TO IT PRODUCING EXTRA STIMULUS NOISE, CAUSING INTERMITTENT HIGH IMPEDANCE READINGS. THE CATHETER WAS THEN REMOVED FROM BODY AND A NEW CATHETER WAS USED. THE CABLES WERE CHANGED FIRST. THE PROCEDURE WAS CARRIED OUT WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10835598 ↗
• MalfunctionNov 6, 2020Insufficient Cooling; Device Contamination with Body Fluid; High Readings; Contamination /Decontamination Problem; Insufficient Cooling; Device Contamination with Body Fluid; High Readings; Contamination /Decontamination Problem

  A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETERS FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED FOREIGN MATERIAL AT THE TIP OF THE RETURNED CATHETER. DURING THE PROCEDURE, THE CARTO 3 SYSTEM AND THE SMARTABLATE GENERATOR WERE DISPLAYING INACCURATE IMPEDANCE AND TEMPERATURE SPIKES WHEN DELIVERING RF THERAPY WITH THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. WHEN THE PHYSICIAN REMOVED THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETERS FROM THE PATIENT'S BODY, THEY NOTED THE PRESENCE OF CHAR AT THE TIP OF THE CATHETER. IT WAS CONFIRMED THAT THE IRRIGATION FUNCTIONED PROPERLY. THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS REPLACED WITH A LIKE DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. THE CUSTOMER¿S REPORTED ISSUES OF HIGH TEMPERATURE, HIGH IMPEDANCE AND CHAR ON THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETERS ARE NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE USER-DEFINED CUT-OFFS WERE NOT EXCEEDED AND THE POTENTIAL THESE COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10805338 ↗
• MalfunctionOct 15, 2020Unable to Obtain Readings

  INCIDENT DESCRIPTION: THE TEMPERATURE SENSOR ON THE CATHETER TIP MALFUNCTIONED. IT MALFUNCTIONED MORE THAN HALFWAY THROUGH THE ABLATION PROCEDURE. THE DOCTOR COULD NOT SEE THE TEMPERATURE DURING THE ABLATION. MD HAD TO GET A NEW ABLATION CATHETER. FROM THE PROCEDURAL NOTE: RADIOFREQUENCY ABLATION WAS PERFORMED WITH THE F/J BIOSENSE-WEBSTER SMARTTOUCH ABLATION CATHETER. INITIALLY, ABLATION WAS PERFORMED RETROGRADELY THROUGH THE AORTA, AND THE CATHETER WAS REPOSITIONED IN THE ANTRUM AND AORTIC MITRAL CONTINUITY. WITH THE ABLATION IN THIS LOCATION, THE PATIENT HAD SUPPRESSION OF VENTRICULAR ECTOPY, BUT WAS NOT COMPLETELY ELIMINATED. ABLATION WAS GUIDED BY PACE MAPPING AND ACTIVATION MAPPING. THEREFORE, THE ABLATION CATHETER WAS THEN POSITIONED TRANSSEPTAL INTO THE ANTERIOR MITRAL ANNULUS AND ABLATION IN THIS LOCATION ELIMINATING VENTRICULAR ECTOPY. AFTER 20 MINUTES OF OBSERVATION, THE PATIENT DID NOT HAVE ANY VENTRICULAR ECTOPY. THERE WERE NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10683038 ↗
• DeathSep 29, 2020Adverse 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 ON (B)(6) 2020 WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND VESSEL DISSECTION (REQUIRING SURGICAL INTERVENTION) AND DEATH. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS BENT AND WAS NOT DEFLECTING PROPERLY TO THE F CURVE. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. NO PATIENT CONSEQUENCE WAS REPORTED. THE REPORTED DEFLECTION ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. INSUFFICIENT DEFLECTION OR NOT RELAXING COMPLETELY (WITHOUT STUCK IN THE DEFLECTED POSITION) WOULD CAUSE INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY WAS REMOTE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2020. POST-PROCEDURE WHILE THE PATIENT WAS IN RECOVERY, THE PATIENT HAD DEVELOPED SOME INTERNAL BLEEDING. IT WAS BELIEVED THE PATIENT HAD AN AORTIC DISSECTION; HOWEVER, IT IS UNKNOWN HOW THE DISSECTION WAS DISCOVERED OR CONFIRMED. IT HAD BEEN NOTED THAT THE PATIENT HAD BEEN STABLE THROUGHOUT THE PROCEDURE. ADDITIONAL SURGERIES WERE REQUIRED. IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2020. NO FURTHER INFORMA

  Patient problems: Death; No Code Available; Vascular Dissection

  MAUDE report 10603943 ↗
• MalfunctionAug 27, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THERE WAS NO SIGNAL AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM. DURING THE PROCEDURE, WHEN THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER WAS CONNECTED, THE BODY SURFACE (BS) AND CORONARY SINUS (CS) SIGNALS WERE LOST. WHEN THE CATHETER WAS DISCONNECTED THE ELECTROCARDIOGRAMS AND SIGNALS RETURNED. THE CABLE WAS REPLACED, BUT THE ISSUE REMAINED. THE PROBLEM WAS SOLVED BY REPLACING THE THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. THE PROCEDURE WAS THEN CONTINUED WITH NO FURTHER ISSUES. NO PATIENT CONSEQUENCES WERE REPORTED. THE CARTO 3 SYSTEM WAS OPERATING PER SPECIFICATIONS AND WAS NOT RESPONSIBLE FOR THE PRODUCT ISSUE. IT WAS REPORTED THAT THE CATHETER HAS BEEN DETERMINED TO BE THE ROOT CAUSE OF THE COMPLAINT REPORTED. ORIGINALLY THE REPORTED SIGNAL ISSUE WAS ASSESSED AS NOT MDR REPORTABLE AS THE RISK TO THE PATIENT WAS LOW. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 30, 2020 CLARIFYING THAT THERE WAS SIGNAL LOSS OBSERVED ON ALL CHANNELS ON BOTH THE CARTO 3 SYSTEM AS WELL AS THE CARDIO LAB RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10463392 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT ATRIAL FIBRILLATION (AFIB) ABLATION WITH THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. DURING ABLATION PHASE, SHORTLY AFTER TRANSSEPTAL THROUGH THE ATRIOSEPTAL DEFECT (ASD) A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 3 LITTERS OF FLUID WERE REMOVED AND PROCEEDED WITH OPEN HEART SURGERY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE OPINION OF THE PHYSICIAN IS THAT THE SHEATH AND NEEDLE WERE INSERTED THROUGH ATRIOSEPTAL DEFECT (ASD) AND PERFORATED THROUGH LEFT ATRIAL APPENDAGE (LAA). THUS, THE CAUSE OF THE EVENT IS PATIENT CONDITION/PROCEDURE. PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY OPEN HEART SURGERY TO CLOSE ASD AND REPAIR HOLE. THE PATIENT¿S CONDITION IS IMPROVED AND STABLE. THE PATIENTS REQUIRED EXTENDED HOSPITALIZATION FOR POST SURGERY RECOVERY. PRIOR TO NOTI

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 10242598 ↗

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-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-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-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-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-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