EZ Steer ThermoCool NAV BNI75TCDFHRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10846835003338), received between Nov 7, 2016 and Sep 29, 2026 — classified as 2 deaths, 26 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Device Sensing Problem; Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50941066 ↗
• MalfunctionSep 25, 2026Delivered as Unsterile Product

  It was reported that a patient underwent a cardiac ablation procedure and when the medical team opened a EZ Steer ThermoCool NAV, "the product was contaminated upon opening". The device was not used inside of the patient's body. A new EZ Steer was opened. Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available to clarify the exact 'contamination', its potential source, or the condition of the packaging.No patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903476 ↗
• InjuryAug 25, 2026Patient Device Interaction Problem

  It was reported that a patient underwent an idiopathic ventricular tachycardia ablation procedure with an EZ Steer ThermoCool NAV catheter and the patient experienced cardiac tamponade which required pericardiocentesis.Toward the end of the premature ventricular contraction ablation, it was noticed that the patient had developed a pericardial effusion on intracardiac echocardiogram. At one point, the patient's blood pressure dropped significantly. A pericardiocentesis was performed to drain the effusion, and the patient's blood was "auto-transfused." The patient's blood pressure recovered, they were stable and awake when case was completed. Because of the volume of blood that was transfused, the decision was made to transport the patient to the surgical unit. Current patient status was stable.Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available.

  Patient problems: Cardiac Tamponade

  MAUDE report 50435340 ↗
• MalfunctionDec 23, 2025Insufficient Cooling; Obstruction of Flow; High Readings; Insufficient Cooling; Obstruction of Flow; High Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER THERMOCOOL NAV CATHETER AND THE SMARTABLATE PUMP KIT-WW. THE CATHETER HAD BLOCKED CHANNELS (DEVICE USED IN PATIENT). TEMPERATURE AND IMPEDANCE NOT ACTING AS EXPECTED. IT SEEMED LIKE THE CATHETER HAD BLOCKED CHANNELS. TOOK SOME PICTURES FROM ABLATION. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025. THE TEMPERATURE VALUE WAS DISPLAYED HIGH. THE SYSTEM STOPPED THE ABLATION WHEN THE CUT OFF VALUE EXCEEDED. THE SMARTABLATE GENERATOR WAS USED WITH DEFAULT THERMOCOOL SETTINGS. THE IMPEDANCE VALUE DISPLAYED AT BOTH HIGH AND LOW. THE SYSTEM STOPPED ACCORDINGLY. CONFIRMATION RECEIVED INDICATED THAT THE ¿BLOCKED CHANNELS¿ REFERRED TO AN IRRIGATION ISSUE. THE SUSPECTED DEVICE FOR THE FLOW / IRRIGATION ISSUE WAS THOUGHT TO BE THE PUMP MALFUNCTIONING. THE EZ STEER THERMOCOOL NAV CATHETER WAS USED IN THE PATIENT. NO ERRORS, JUST PROBLEMS WITH TEMPERATURE AND IMPEDANCE. NEW PUMP WAS USED. THE SMARTABLATE GENERATOR KIT-WW AND SMARTABLATE PUMP KIT-WW WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882887 ↗
• InjuryDec 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING CARDIAC ABLATION WITH EZ STEER THERMOCOOL NAV CATHETER, THE PATIENT EXPERIENCED DROP IN BLOOD PRESSURE, CARDIAC ARREST, CARDIAC TAMPONADE TREATED WITH CARDIOPULMONARY RESUSCITATION AND DRAINAGE. AFTER INTRODUCING PERCUTANEOUS CARDIOPULMONARY SUPPORT, THORACOTOMY WAS PERFORMED AND PERFORATION WAS NOTED AT THE LATERAL SIDE OF THE BASE OF LEFT VENTRICLE. AFTER COMPLETING ABLATION AT THE CUSP, DURING PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED, LEADING TO CARDIAC ARREST, AND CARDIOPULMONARY RESUSCITATION WAS INITIATED. CARDIAC TAMPONADE WAS REPORTED AND DRAINAGE WAS CONDUCTED, AND VITALS TEMPORARILY STABILIZED, BUT THEN DETERIORATED AGAIN. AFTER INTRODUCING PERCUTANEOUS CARDIOPULMONARY SUPPORT, THORACOTOMY WAS PERFORMED. THE ABLATION SITES WERE THE CUSP AND NEAR THE LEFT VENTRICULAR OUTFLOW TRACT, 25-30W FOR 60 SECONDS. ABLATION CATHETER WAS A TC (TACTICATH BY ABOTT, SO THERE WAS NO CONTACT FORCE MEASUREMENT). VISUAL IMPDROP INDICATOR SHOWED ABLATION, AND DURING THE FINAL ABLATION, THERE WAS NO EXCESSIVE IMPEDANCE DECREASE OR INCREASE. EXTENDED HOSPITALIZATION WAS NOTED. VISITAG COLORING SETTING WAS TOTAL TIME. THE PHYSICIAN'S OPINIONS ON TH

  Patient problems: Cardiac Arrest; Cardiac Perforation

  MAUDE report 23762449 ↗
• InjuryOct 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A CATHETER ABLATION OF THE SLOW PATHWAY (CASP) PROCEDURE WITH AN EZ STEER THERMOCOOL NAV CATHETER, THE PATIENT EXPERIENCED A CARDIAC BLOCK TREATED WITH INSERTION OF TEMPORARY PACEMAKER. DURING THE PROCEDURE FOR PVC FROM THE LEFT LEG, DURING ABLATION FROM CATHETER ABLATION OF THE SLOW PATHWAY (CASP), BRADYCARDIA AND CARDIAC BLOCK OCCURRED WHEN THE DECANAV CATHETER SHIFTED BELOW THE VALVE. A TEMPORARY PACEMAKER WAS INSERTED, AND THE PATIENT WAS UNDER FOLLOW-UP OBSERVATION. THE PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS SERIOUS. NO PROLONGATION OF HOSPITAL STAY WAS NOTED. THE CONTACT FORCE (CF) MONITORING METHOD WAS VISITAG. THE COLORING SETTING OF VISITAG WAS TAG INDEX. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS NO CAUSAL RELATIONSHIP. NO ABNORMALITIES OBSERVED PRIOR/DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS NOT RELATED TO THE PRODUCTS.

  Patient problems: Heart Block

  MAUDE report 23317942 ↗
• MalfunctionAug 7, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A LIFTED ELECTRODE ALONG WITH A PULLER WIRE BROKEN INSIDE OF THE HANDLE. NO INTERNAL COMPONENTS WERE EXPOSED. DURING THE PROCEDURE, THE DOCTOR WAS ADJUSTING THE CURVE IN THE CHAMBER WHEN THE KNOB BROKE, MAKING IT IMPOSSIBLE TO TURN TO THE D CURVE. NO ERROR CODE OCCURRED. THE CATHETER WAS REPLACED. 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 22745577 ↗
• InjuryJun 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED THAT DURING PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH A EZ STEER THERMOCOOL NAV, THE PATIENT EXPERIENCED TAMPONADE TREATED WITH PERICARDIOCENTESIS. TACHYCARDIA STARTED (350MS, CS1-2 FIRST). LOCAL ACTIVATION TIME (LAT) MAP OF LEFT ATRIUM (LA) WITH ABLATION CATHETER (THERMOCOOL) STARTED. LAT MAPPING OF THE LA WITH ABLATION CATHETER, FAST ANATOMICAL MAPPING (FAM) WAS CREATED IN A STRUCTURE IN THE RIGHT ANTERIOR SUPERIOR SIDE OF THE LA. THE PHYSICIAN THOUGHT IT WAS A SMALL ROOF VEIN. EARLY POINT APPEARED BETWEEN RIGHT SUPERIOR PULMONARY VEIN (RSPV) AND THIS UNKNOWN STRUCTURE. PHYSICIAN TRIED TO ABLATE IN BETWEEN, BUT CATHETER WAS FALLING INTO THIS STRUCTURE, AND ABLATION WAS BEING STOPPED DUE TO HIGH TEMPERATURE. IMPEDANCE WAS NORMAL. PHYSICIAN TOOK THE ABLATION CATHETER OUT AND INJECTED CONTRACT IN THIS UNKNOWN STRUCTURE, AND REALIZED IT WAS NOT A SMALL ROOF VEIN. AN ECHO FOUND THE TAMPONADE, AND PERICARDIOCENTESIS WAS PERFORMED. PATIENT BLOOD PRESSURE BECAME STABLE, AND PROCEDURE FINISHED. THE PHYSICIAN BELIEVED TAMPONADE WAS CREATED DURING MAPPING WITH ABLATION CATHETER. AT THE START OF THE PROCEDURE, THE PHYSICIAN HAD PROBLEMS WITH THE TRANSSEPTAL,

  Patient problems: Cardiac Tamponade

  MAUDE report 22293710 ↗
• MalfunctionMar 24, 2025Coagulation 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 A CARDIAC ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND THERE WAS CHARRING ON SIDE OF THE TIP ELECTRODE. THE PHYSICIAN CONSIDERED THE AMOUNT OF CHARRING TO PRESENT A PATIENT RISK. THERE WERE NO ISSUES RELATED TO THE CATHETER, PUMP, AND GENERATOR SETTINGS. THE PATIENT WAS ANTICOAGULATED WITH AN ACTIVATED CLOTTING TIME (ACT) OF 300 MAINTAINED THROUGHOUT THE CASE. NO ERROR MESSAGES OR PRODUCT PROBLEMS WERE NOTED. DETAILS REGARDING TROUBLESHOOTING OR THE COMPLETION OF THE PROCEDURE WERE NOT PROVIDED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682958 ↗
• MalfunctionOct 29, 2024Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND THERE WAS AN IRRIGATION ISSUE. THE MEDICAL TEAM NOTED THAT THE TEMPERATURE WAS TOO HIGH DURING ABLATION (OVER 40). THEN THEY NOTICED THAT THE IRRIGATION HOLE WAS BLOCKED DURING FLUSH. THE ISSUE WASN'T NOTED UNTIL THE DEVICE WAS BEING USED ON THE PATIENT. THE TEAM REMOVED THE DEVICE FROM THE PATIENT AND ATTEMPTED TO FLUSH, WHICH WAS WHEN THEY FOUND THE IRRIGATION BLOCKAGE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO FLOW RATE CHANGE ISSUES NOTED AT THE START OF ABLATION. THE CATHETER WAS CHANGED AND THE TEMPERATURE NORMALIZED AGAIN. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563431 ↗
• InjuryJan 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS. RF NEEDLE WAS NOT USED FOR TRANSSEPTAL PUNCTURE. ABLATION WAS PERFORMED. ONE HOUR AFTER THE PROCEDURE WAS STARTED AND DURING THE ABLATION, IMPEDANCE INCREASED MID-ABLATION. THE ABLATION WAS IMMEDIATELY STOPPED, BUT THE BLOOD PRESSURE DECREASED. NO STEAM POPS HAVE BEEN CONFIRMED. PERICARDIAL DRAINAGE WAS PERFORMED AND BLOOD PRESSURE WAS STABILIZED. THE PATIENT WAS CONSCIOUS, BUT RETURNED TO THE ICU FOR MONITORING. THE PATIENT'S CONDITION IMPROVED AT THIS POINT. NO ERROR MESSAGES ON EQUIPMENT DURING PROCEDURE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THE PROCEDURE. THE PHYSICIAN MENTIONED THAT RIGHT VENTRICULAR OUTFLOW TRACT, THE SITE OF ABLATION, IS NORMALLY INDENTED, BUT THE PATIENT'S RIGHT VENTRICULAR OUTFLOW TRACT WAS APPEARED EVEN MORE INDENTED THAN OTHERS ON THE COMPUTED TOMOGRAPHY (CT) SCAN. THE PATIENT'S BREATH WAS DEEP, SO THE TIP OF THE CATHETER MAY HAVE BEEN STUCK IN THE INDENTED HOLLOW DURING ABLATION, RESULTING IN CARDIAC TAMPONADE. THE PATIENT BECAME STABLE AND MOVED TO GENERAL WARD ON THE DAY AFTER THE PROCEDU

  Patient problems: Cardiac Tamponade

  MAUDE report 18489530 ↗
• MalfunctionDec 12, 2023Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/(WPW) PROCEDURE WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND AN IRRIGATION ISSUE OCCURRED. AN ERROR WAS DETECTED ON THE SMARTABLATE DUE TO A TEMPERATURE INCREASE, CAUSING THE APPLICATION TO CRASH. THE PATIENT'S EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER WAS REMOVED AND THE IRRIGATION WAS INCREASED TO 70. THEY FOUND THAT IT WAS CLOGGED AND WAS NOT IRRIGATING PROPERLY. SURGERY DELAYED 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THIS ISSUE WAS NOTED DURING THE DEVICE WAS USED ON THE PATIENT. THE ISSUE WAS DISCOVERED ON THE SMARTABLATE DUE TO TEMPERATURE INCREASE, CAUSING THE APPLICATION TO CRASH. THE PATIENT'S EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER WAS REMOVED AND THE IRRIGATION WAS INCREASED TO 70. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS NOT SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE TEMPERATURE INCREASE CAUSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314047 ↗
• InjuryDec 7, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE FOR VENTRICULAR TACHYCARDIA (VT) WHICH INCLUDED THE USE OF AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND EXPERIENCED HEART BLOCK REQUIRING IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) FOR AN INTERVENTION AND HOSPITALIZATION. THE EVENT OCCURRED WHEN THE SEPTUM OF LEFT VENTRICLE (LV) WAS ABLATED BY THERMOCOOL DURING VT IN THE MIDDLE OF THE PROCEDURE, AND WHEN THE VT WAS TERMINATED. THE PROCEDURE WAS CONTINUED AS IT WAS AND COMPLETED WITHOUT ANY PROBLEM. THE PATIENT STILL HAD THE LEFT BUNDLE BRANCH BLOCK WHEN LEAVING THE ROOM. THIS EVENT WAS INITIALLY ASSESSED AS NON MDR REPORTABLE. HOWEVER, ON 09-NOV-2023, ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WAS IMPLANTED IN THE PATIENT. THE PATIENT RECOVERED WITH NO DISABILITIES THAT INTERFERES WITH DAILY ACTIVITY AFTER AN EXTENDED HOSPITALIZATION. WITH THE ADDITIONAL INFORMATION RECEIVED, THIS EVENT IS NOW CONSIDERED MDR REPORTABLE. THE AWARENESS DATE WAS 09-NOV-2023.

  Patient problems: Heart Block

  MAUDE report 18280662 ↗
• InjuryJun 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT AFTER COMPLETION OF THE PROCEDURE, POOR CARDIAC SHADOWING WAS SHOWED BY FLUOROSCOPY AND PERICARDIAL EFFUSION VOLUME WAS CONFIRMED BY ECHOCARDIOGRAPHY. BLOOD PRESSURE DROPPED TO THE 60S, BUT THE PATIENT WAS CLEARLY CONSCIOUS. TIMING WAS IMMEDIATELY AFTER COMPLETION OF THE PROCEDURE, BY THE ECHOCARDIOGRAPHY. PERICARDIAL DRAINAGE WAS PERFORMED, BLOOD PRESSURE WAS STABILIZED, AND THE PATIENT RETURNED TO INTENSIVE CARE UNIT (ICU). ATRIAL SEPTAL PUNCTURE WAS PERFORMED. SEPTAL PUNCTURE WAS PERFORMED WITH FUKUDA DENSHI RF NEEDLE AND ABLATION WAS CONDUCTED IN THE LEFT VENTRICLE. ABLATION WAS PERFORMED BEFORE THE CARDIAC TAMPONADE WAS DETECTED. STEAM POP WAS NOT CONFIRMED. IRRIGATION CATHETER WAS USED, THE FLOW RATE SETTING WAS PRE 1 SEC., POST 5 SEC. SETTING, IRRIGATION 17ML, HIGH FLOW 30ML, NO CHANGE AFTER THE PERICARDIAL DRAINAGE, THE BLOOD PRESSURE RETURNED TO THE 100S AND STABILIZED, AND CONSCIOUSNESS WAS CLEAR THROUGHOUT THE PROCEDURE. THE PATIENT WAS FOLL

  Patient problems: Cardiac Tamponade

  MAUDE report 17188089 ↗
• DeathJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AV NODE ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED PULMONARY EMBOLISM AND CARDIAC ARREST AND ULTIMATELY PASSED AWAY. IT WAS REPORTED THAT DURING AN AV (ATRIOVENTRICULAR) NODE ABLATION, THE PHYSICIAN BELIEVES THERE WAS A PULMONARY EMBOLISM IN THE PATIENT, AND THE PATIENT CODED. THEY REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED. THEY CODE WAS THEN CALLED FOR THE PATIENT. THE CHEST COMPRESSIONS WERE ADMINISTERED TO THE PATIENT, ALONG WITH SEVERAL DEFIBRILLATION ATTEMPTS, WITHOUT SUCCESS. THE MEDICAL TEAM REPORTED AT THIS POINT THE PATIENT'S BLOOD PRESSURE WAS STILL LOW, WITH A HIGH HEART RATE. THE PATIENT WAS THEN ADMINISTERED EPINEPHRINE AND ATROPINE. THEY THEN REPORTED THAT AFTER ABOUT 15-30 MINUTES OF CPR, THE PATIENT WAS CALLED DECEASED AT 4:00PM. THE PHYSICIAN DOES NOT BELIEVE THE THERMOCOOL CATHETER WAS CAUSE OF THE ISSUE. THE PHYSICIAN BELIEVES THAT A PULMONARY EMBOLISM WAS THE CAUSE, BUT THIS INFORMATION COULD NOT BE CONFIRMED. ALL DEATHS WERE BWI. FDA APPROVED ¿ CE MARK DEVICES ARE INVOLVED ARE REPORTABLE.

  Patient problems: Cardiac Arrest; Pulmonary Embolism

  MAUDE report 17164656 ↗
• InjuryMar 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDVT ¿ RIGHT ABLATION PROCEDURE WITH A SOUNDSTAR ECO AND EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THEY STATED THAT DURING THE FIST ABLATION AT 1 MIN 54 SECONDS IN IT WAS NOTED BY ANESTHESIA THAT THE PATIENT¿S PRESSURE DROPPED. THE ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER WAS USED TO CONFIRM A LARGE PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND 3345 CC'S OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT ALSO RECEIVED 1005 CC'S BACK THROUGH ONE OF THE GROIN SHEATHS. A CARDIOTHORACIC SURGEON WAS BROUGHT IN FOR CONSULT, AND THE PATIENT WAS THEN TAKEN TO SURGERY. THEY STATED THAT THE PATIENT WAS CURRENTLY IN THE SURGERY AT THE TIME OF THE CALL. THEY REPORTED THAT THE WATTAGE USED RANGED FROM 5-23 WATTS WITH 15 WATTS AS THE AVERAGE. THEY STATED THERE WAS SPECULATION THAT THE PERFORATION WAS CAUSED BY ABLATION INSIDE THE CS, BUT HAD NOT HAD A CHANCE TO HAVE A REAL DISCUSSION WITH THE PHYSICIAN. OTHER BWI PRODUCTS IN USE: DECANAV AND SOUNDSTAR. THE ADVERSE EVENT OCCURRED ON

  Patient problems: Cardiac Tamponade

  MAUDE report 16479237 ↗
• InjuryJul 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. AFTER DOING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE AND AFTER THE ISOLATION OF ALL 4 VEINS, THE PHYSICIAN RETRACTED THE SHEATH FROM LEFT ATRIUM TO RIGHT ATRIUM TO CHECK THE CTI LINE. AT THAT POINT, HE SAW A DRASTIC PRESSURE CHANGE AND HE REALIZED THAT THERE WAS A CARDIAC TAMPONADE (LIKELY DUE TO TRANSSEPTAL PUNCTURE NOT DONE EXACTLY AT THE FOSSA OVALIS SITE). HE STOPPED IMMEDIATELY THE PROCEDURE AND WAS ABLE TO STOP THE BLEEDING, TAKING OUT ALL THE BLOOD IN THE PERICARDIUM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS DUE TO TRANSSEPTAL PUNCTURE DURING THE PROCEDURE. THIS WAS A PVI CASE, AND A PERFORATION OF THE HEART CHAMBER OCCURRED DUE TO TRANSSEPTAL PUNCTURE. THE PATIENT OUTCOME OF THE ADVERSE EVENT FROM THE LAST UPDATE PROVIDED IS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. A TRANSSEPTAL PUNCTURE WAS PERFORMED USING AN ABBOTT BRK TSP NE

  Patient problems: Cardiac Tamponade

  MAUDE report 14950992 ↗
• InjuryJun 21, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND SUFFERED PERICARDIAL EFFUSION AND THE SURGERY WAS DELAYED 120 MINUTES. WHILE MAPPING THE RIGHT VENTRICLE OUTFLOW TACK (RVOT), USING THE THERMOCOOL D-F CATHETER, THE PATIENT STARTED COMPLAINING OF CHEST PAIN AND SUDDENLY HIS HEART RATE DROPPED, THEREFORE RV PACING WAS INITIATED AND A CARDIAC ECHO WAS PERFORMED WHERE A SMALL PERICARDIAL EFFUSION WAS NOTICED. A FEW MINUTES LATER, THE PATIENT RECOVERED AND HIS HEART RATE WENT BACK TO NORMAL SO PACING WAS STOPPED. CARDIAC ECHO WAS REPEATED 4 TIMES EVERY 30 MINUTES CONFIRMING THAT PERICARDIAL EFFUSION DID NOT GET WORSE. AT THIS STAGE, THE PHYSICIAN DECIDED TO ABORT THE CASE AND RESCHEDULE IT FOR LATER TO AVOID ANY FURTHER COMPLICATIONS TO THE PATIENT. THE PROCEDURE WAS DELAYED BY 120 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS DUE TO THE PATIENT¿S HEART ANATOMY, AS HE MIGHT HAVE A THIN CARDIAC WALL IN THE RVOT AREA WHICH WAS MAPPED. NO INTERVENTION WAS PROVID

  Patient problems: Pericardial Effusion

  MAUDE report 14762501 ↗
• InjuryMay 4, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED RIGHT CORONARY ARTERY ANEURYSM REQUIRING SURGICAL INTERVENTION. DURING EPICARDIAL ABLATION, WHEN CORONARY ANGIOGRAPHY (CAG) WAS CONDUCTED, AN ANEURYSM WAS CONFIRMED AT THE PERIPHERY OF THE RIGHT CORONARY ARTERY. ALTHOUGH IT WAS UNKNOWN WHETHER THE ISSUE WAS CAUSED BY ABLATION, PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. THIS OCCURRED AFTER ABLATION, WHEN PERICARDIAL DRAINAGE WAS PERFORMED. THE ISSUE WAS RESOLVED BY CONDUCTING THE PCI. THE PROCEDURE WAS ENDED WITHOUT PROBLEM AND THE PATIENT RETURNED TO THE WARD. CORONARY ARTERY INJURY; SINCE THE CATHETER HAD NO CONTACT FORCE (CF), THERE WAS NO CF MONITORING; IT WAS CONFIRMED BY FLUOROSCOPY BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM AFTER PCI. THE PHYSICIAN WILL DESCRIBE THEIR OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT AFTER CHECKING. MEDICAL HISTORY/TREATMENT HISTORY/OTHER DISEASES CURRENTLY BEING TREATED INCLUDES BRUGADA ELECTROCARDIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THIS ADVERSE EVEN

  Patient problems: Perforation of Vessels

  MAUDE report 14284199 ↗
• InjuryJan 9, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED VENTRICULAR FIBRILLATION AND CARDIAC ARREST REQUIRING CHEST COMPRESSIONS. IT WAS REPORTED THAT DURING ABLATION, THE PATIENT¿S HEART RATE INCREASED DUE TO THE ABLATION EFFECT, AND IT BROKE DOWN AND BECAME VENTRICULAR FIBRILLATION, BUT DID NOT OCCUR THEREAFTER. THIS OCCURRED DURING ABLATION. THE PATIENT RETURNED TO SINUS MODE BY DC. IN THE SAME WAY, VF BECAME 5 TIMES WHEN ABLATION WAS PRESENT, DC WAS INJECTED TWICE, AND THE REMAINING 2 TIMES STOPPED SPONTANEOUSLY WITH CHEST COMPRESSION. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED. THE PHYSICIAN COMMENTED THAT IN PARTICULAR, THEY TENDED TO HAVE REACTIONS TO ABLATION. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. IT WAS RETURNED TO SINUS MODE BY DC. IN THE SAME WAY, VF BECAME 5 TIMES WHEN ABLATION WAS PRESENT, DC WAS INJECTED TWICE, AND THE REMAINING 3 TIMES STOPPED SPONTANEOUSLY WHEN CHEST COMPRESSION. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMAT

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 13201250 ↗
• InjuryNov 2, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT ((B)(6)) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. PERICARDIAL EFFUSION WAS DETECTED DURING TREATMENT, DURING USE OF BIOSENSE WEBSTER PRODUCTS, AND TREATMENT WAS DISCONTINUED. CARDIAC TAMPONADE WAS DIAGNOSED AND DRAINAGE WAS PERFORMED, BUT HEMOSTASIS COULD NOT BE ACHIEVED, SO THORACOTOMY WAS PERFORMED. THE PHYSICIAN COMMENTED THAT IT MAY BE DUE TO STEAM POP. THE OPERATION WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS RESTING. THE PHYSICIAN COMMENTED THAT SINCE THERE WAS A HOLE IN THE SITE DIFFERENT FROM THE SITE WHERE IT NOTICED THE STEAM POP, IT WAS SUSPECTED TO BE DUE TO EXCESSIVE ABLATION AT A DIFFERENT SITE FROM THE STEAM POP SITE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. DRAINAGE AND THORACOTOMY WERE PERFORMED FOR INTERVENTION. PATIENT OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS IMPROVED. PRIOR TO NOTING THE CARDIAC TAMPONADE (CT) ABLATION HAD ALREADY PERF

  Patient problems: Cardiac Tamponade

  MAUDE report 12741534 ↗
• InjuryOct 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH AN EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) / VENTRICULAR TACHYCARDIA IDIOPATHIC CASE, A PERICARDIAL EFFUSION WAS NOTICED. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PERICARDIAL EFFUSION WAS DISCOVERED AND CONFIRMED WITH ULTRASOUND BY THE PHYSICIAN. MEDICAL INTERVENTION PROVIDED WAS A "DRAIN" AND 300 ML OF FLUID WAS REMOVED. THE PROCEDURE WAS ABORTED AND NOT COMPLETED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: IS THAT IT WAS CAUSED BY A NON BWI PRODUCT. THE PHYSICIAN STATES THE EVENT OCCURRED DURING CORONARY SINUS (CS) VENOGRAM. PATIENT OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS RECOVERED. IT IS UNKNOWN IF THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. GENERATOR USED WAS A SMARTABLATE. TRANSSEPTAL PUNCTURE WAS PERFORMED. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION HAD NOT BEEN PERFORMED. IR

  Patient problems: Cardiac Tamponade

  MAUDE report 12602428 ↗
• InjuryAug 16, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED COMPLETE HEART BLOCK REQUIRING INDWELLING ICD TO HAVE PACER SETTINGS ACTIVATED. DURING ABLATION THE PATIENT HAD AV BLOCK. THE PATIENT ORIGINALLY HAD AN ICD, AND WE PUT V PACE. THE PATIENT ORIGINALLY HAD AN ICD AND LEFT THE ROOM WITH A DDD SETTING WITH A V-PACE. THE PHYSICIAN COMMENTED THAT WHEN ABLATION WAS DONE, THE CATHETER JUMPED. ADDITIONAL INFORMATION: THEY SAID IT REMAINED 8/3 COMPLETE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN ICD AND V PACING WAS ADDED. THE ADVERSE EVENT OCCURRED DURING USE OF BWI PRODUCTS. THE PATIENT'S CONDITION WAS REPORTED AS HAVING IMPROVED. SINCE THIS EVENT IS LIFE THREATENING AND REQUIRED INTERVENTIONS TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THEN IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

  Patient problems: Heart Block

  MAUDE report 12322691 ↗
• InjuryAug 16, 2021Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A EZ STEER THERMOCOOL NAVIGATION. DURING THE PROCEDURE THE ABLATION CATHETER WAS HOOKED TO THE LEAD WHEN IT WAS ABOUT TO BE PLACED IN THE CAROTID SINUS (CS) AND THE ATRIAL LEAD WAS REMOVED. THIS REQUIRED SURGICAL INTERVENTION TO REPLACE THE LEAD. ATRIAL LEAD REMOVED WHEN THE ABLATION CATHETER WAS HOOKED TO THE LEAD WHEN IT WAS ABOUT TO BE PLACED IN THE CS. NO PROCEDURE WAS PERFORMED TODAY, AND ABLATION WAS CONTINUED. THE LEAD WILL BE RE-IMPLANTED NEXT WEDNESDAY. THE PHYSICIAN COMMENTED THAT WHEN AN ATTEMPT WAS MADE TO PLACE THE ABLATION CATHETER IN THE CS, IT CAUGHT THE LEAD AND CAME OUT. THE ATRIAL LEAD OF ANOTHER COMPANY'S PRODUCT HAS COME OFF. THE EZ STEER THERMOCOOL NAVIGATION WAS ENTANGLED WITH THE LEAD. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: PROCEDURE. THE INTERVENTION PROVIDED: THE REPLACEMENT OF THE LEAD IS PLANNED. PATIENT OUTCOME OF THE ADVERSE EVENT: UNCHANGED. A SMARTABLATE GENERATOR WAS USED. THE MEDICAL DEVICE ENTRAPMENT IS MDR-REPORTABLE AS SURGICAL INTERVENTION WAS REQUIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322604 ↗
• InjuryJul 19, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH AN EZ STEER" THERMOCOOL¿ NAV BI-DIRECTIONAL CATHETER AND THE PATIENT SUFFERED HEART BLOCK AV REQUIRING TEMPORARILY PACING WIRE TO BE INSERTED AND PLANNING FOR A CARDIAC RESYNCHRONIZATION THERAPY WITH DEFIBRILLATION (CRT-D). DURING A VT ABLATION WHEN TACHYCARDIA WAS STOPPED, AV BLOCK WAS PRESENT. A TEMPORARY PACEMAKER WAS INSERTED. THE PHYSICIAN COMMENTED THAT ORIGINALLY, THERE WERE SEVERAL TYPES OF VT, AND TODAY'S VT IS CLOSE TO HIS, SO I JUST NEED TO STOP THE TACHYCARDIA. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIANS OPINION ON THE CAUSE OF THIS ADVERSE EVEN WAS THAT IT WAS PATIENT CONDITION RELATED. THE ORIGIN OF THE VT WAS CLOSE TO HIS-BUNDLE. PATIENT OUTCOME WAS REPORTED AS IMPROVED. IT WAS NOT REPORTED THAT EXTENDED HOSPITALIZATION WAS REQUIRED.

  Patient problems: Heart Block

  MAUDE report 12192923 ↗

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-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-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-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-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-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