ThermoCool SF NAVRecalls & reported problems across all models

We found 17 models of ThermoCool SF NAV by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2016 and Dec 5, 2025 — classified as 9 deaths, 81 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (27 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ThermoCool SF NAV problems

ThermoCool SF NAV models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ThermoCool SF NAV BNI35DFH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 death22 reports
• ThermoCool SF NAV BNI35DFCT

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  3 deaths18 reports
• ThermoCool SF NAV BNI35BDH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  12 reports
• ThermoCool SF NAV BNI35FJCT

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 death11 reports
• ThermoCool SF NAV D131503

  Cardiac ablation percutaneous catheter
  9 reports
• ThermoCool SF NAV BNI35BDCT

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 death6 reports
• ThermoCool SF NAV D131802

  Cardiac ablation percutaneous catheter
  6 reports
• ThermoCool SF NAV BNI35BBH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  5 reports
• ThermoCool SF NAV BNI35DDH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  5 reports
• ThermoCool SF NAV D131502

  Cardiac ablation percutaneous catheter
  4 reports
• ThermoCool SF NAV BNI35BFH

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 death3 reports
• ThermoCool SF NAV D131803

  Cardiac ablation percutaneous catheter
  2 deaths3 reports
• ThermoCool SF NAV D131501

  Cardiac ablation percutaneous catheter
  2 reports
• ThermoCool SF NAV BNI35BFCT

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 report
• ThermoCool SF NAV BNI35FFCT

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 report
• ThermoCool SF NAV BNI35JJCT

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 report
• ThermoCool SF NAV D131504

  Cardiac ablation percutaneous catheter
  1 report

Recent ThermoCool SF NAV adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CATHETER ABLATION PROCEDURE WAS PERFORMED WITH A THERMOCOOL SF NAV CATHETER TO TREAT PREMATURE VENTRICULAR CONTRACTION AND NON-SUSTAINED VENTRICULAR TACHYCARDIA, THE PATIENT EXPERIENCED PREMATURE VENTRICULAR CONTRACTION RECURRENCE, AND THE CATHETER ABLATION WAS PERFORMED AGAIN. CORONARY VENOGRAPHY REVEALED OCCLUSION IN A PART OF A CORONARY VEIN. DURING THE PROCEDURE ITSELF, THE RIGHT VENTRICULAR OUTFLOW TRACT, LEFT VENTRICULAR OUTFLOW TRACT, AND AREAS NEAR THE CORONARY VEINS WERE ABLATED, AND A TEMPORARY SUPPRESSIVE EFFECT WAS OBSERVED. AFTER THE PROCEDURE (UNKNOWN DATE), PREMATURE VENTRICULAR CONTRACTION RECURRED, AND THE CATHETER ABLATION WAS PERFORMED AGAIN. CORONARY VENOGRAPHY REVEALED OCCLUSION IN A PART OF A CORONARY VEIN. ALTHOUGH THERE WERE NO CLINICAL SYMPTOMS FROM THE OCCLUSION, ABLATION AT THE TARGET SITE WAS DIFFICULT, SO THE PROCEDURE WAS DISCONTINUED. DEFINITIVE CURE FOR PREMATURE VENTRICULAR CONTRACTION WAS NOT ACHIEVED. THE PHYSICIAN'S COMMENT WAS THAT REGARDING THE RECURRENCE, SINCE ACCESS TO THE EARLIEST EXCITATION SITE WITH THE CATHETER WAS DIFFICULT, THE ABLATION HAD TO BE PERFORMED AT A PROXIMAL SITE. IT MAY HAVE CONTRIBUTED TO AN INSUF

  Patient problems: Perforation of Vessels

  MAUDE report 23730088 ↗
• MalfunctionNov 7, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SF NAV AND AN IRRIGATION ISSUE HAPPENED MID PROCEDURE. AFTER THE CATHETER WAS ADVANCED INTO THE BODY, RF (RADIOFREQUENCY) ENERGY WAS APPLIED FOR THE FIRST TIME. THE TEMPERATURE BEGAN TO RISE AND EXCEEDED THE CUT-OFF VALUE, CAUSING THE RF TO STOP AUTOMATICALLY. THE CATHETER CONNECTION CABLES WERE REPLACED. DURING THE SECOND RF ATTEMPT, THE TEMPERATURE AGAIN INCREASED AND REACHED THE CUT-OFF VALUE, RESULTING IN ANOTHER AUTOMATIC SHUTDOWN. WHEN THE CATHETER WAS REMOVED FROM THE BODY, THE MEDICAL TEAM OBSERVED THAT THE IRRIGATION FLUID DID NOT FLOW AT THE PRESET RATE. THE INTERMEDIATE LINE WAS DISCONNECTED, CONFIRMING THAT THE ISSUE WAS NOT DUE TO THE LINE. IT WAS THEN DETERMINED THAT THE CATHETER¿S IRRIGATION SYSTEM WAS OBSTRUCTED, AND THE CATHETER WAS REPLACED WITH A NEW ONE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500635 ↗
• InjuryNov 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION WITH A THERMOCOOL SF NAV CATHETER AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. PVC PROCEDURE WITH ORIGIN IN ANTERIOR RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). AFTER ABLATION, THE PVC¿S WERE SILENT FOR 7 MINUTES AND THEN STARTED AGAIN. DURING MANEUVERING THE CATHETER IN THE RVOT, A PERICARDIAL EFFUSION OCCURRED. DUE TO THIS, PERICARDIAL DRAINAGE WAS NEEDED. 500 ML OF BLOOD WAS DRAWN OUT THE PERICARDIAL SPACE. NO STEAM POP OR IMPEDANCE RISE WAS SEEN OR HEARD DURING ABLATION. ABLATION SETTINGS: 25W, ABLATION TIME: 06:25, TOTAL ABLATIONS: 23. TEMPERATURE: MAX 33 DEGREES. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 20634701 ↗
• InjuryJul 30, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTICULAR CONTRACTION (PVC) CARDIAC ABLATION WITH A VIZIGO SHEATH AND THERMOCOOL SF NAV CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. TWO HOURS AFTER THE START OF THE PROCEDURE, AFTER ABLATING IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) FOR PVC PROCEDURE, DURING RE-MAPPING, THE HEARTBEAT WAS WEAKENED IN CINE. CARDIAC TAMPONADE WAS SUSPECTED AND DRAINAGE WAS PERFORMED. THE PROCEDURE WAS COMPLETED AS IT WAS. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT IS THAT THERE WAS NO FORCEFUL MANIPULATION OR EXCESSIVE ABLATION DURING MAPPING OR ABLATING, BUT BASED ON THE TIMING OF NOTICING THE TAMPONADE, THERE IS A POSSIBILITY THAT SOMETHING WAS CAUGHT BY THE ABLATION CATHETER OR THE SHEATH. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. ABLATION WAS PERFORMED PRIOR TO IDENTIFYING THE TAMPONADE. NO STEAM POPS WERE CONFIRMED. NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS

  Patient problems: Cardiac Tamponade

  MAUDE report 19869183 ↗
• InjuryJul 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR TACHYCARDIA ABLATION WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AFTER ABLATION (FIRST TIME AND DURING FIRST SESSION) WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER, THE PATIENT'S BLOOD PRESSURE DECREASED. ABLATION WAS PERFORMED PRIOR TO PERICARDIAL EFFUSION WAS CONFIRMED. PERICARDIAL DRAINAGE WAS PERFORMED, AND THE PATIENT'S BLOOD PRESSURE NORMALIZED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ABLATION. THE PATIENT HAS FULLY RECOVERED AND DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THE PROCEDURE, HOWEVER IT IS STILL UNKNOWN WHEN THE CARDIAC TAMPONADE OCCURRED. ATRIAL SEPTAL PUNCTURE WAS NOT PERFORMED. STEAM POP WAS NOT CONFIRMED. NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT.

  Patient problems: Cardiac Tamponade

  MAUDE report 19766414 ↗
• InjuryJun 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS LOOKING FOR TARGET SITE, CARDIAC TAMPONADE WAS FOUND TO HAVE OCCURRED. AFTER CARDIAC TAMPONADE WAS FOUND TO HAVE OCCURRED, IT WAS CONFIRMED WHETHER PERICARDIAL EFFUSION WAS ACCUMULATED BY ECHOCARDIOGRAPHY, AND PERICARDIAL DRAINAGE WAS PERFORMED. AFTER THAT, BLOOD PRESSURE RESTORED TO AROUND 100-110. THE PATIENT RETURNED TO ROOM WITH ELECTROCARDIOGRAM MONITOR ON. PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE PHYSICIAN COMMENTED AFTER THE PROCEDURE THAT THERE WAS NO CAUSAL RELATIONSHIP WITH THE PRODUCT. ABLATION WAS PERFORMED PRIOR TO NOTING THE EFFUSION. THE EFFUSION OCCURRED AFTER PSVT WAS ABLATED AND RECURRENCE WAS CONFIRMED, WHEN THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER WAS RE-INSERTED. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED. NO EVIDENCE OF STEAM POP. PATIENT HAS IMPROVED.

  Patient problems: Cardiac Tamponade

  MAUDE report 19620443 ↗
• InjuryApr 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. PERFORMED CAVOTRICUSPID ISHMUS (CTI) ON PATIENT - FAIRLY LONG ABLATION TIME. PULLED ALL CATHETERS OUT OF THE HEART. AT THIS POINT, THE INTERVENTION/ABLATION WAS OVER. PATIENT WENT BRADYCARDIC, ECHO INDICATED PERICARDIAL TAMPONADE. DRAINED TAMPONADE, PATIENT STABILIZED. EXTENDED HOSPITAL STAY. ADDITIONAL INFORMATION WAS RECEIVED. TAMPONADE OCCURRED DURING A CTI ABLATION. POST ABLATION, THE TAMPONADE WAS DISCOVERED. THE PATIENT THEN HAD A VAGAL REACTION AND A TEE CONFIRMED PERICARDIAL TAMPONADE. DRAINAGE WITH A SYRINGE WAS PERFORMED. PATIENT HAD IMPROVED BUT HAD TO STAY TO RECOVER/BE OBSERVED FOR ADDITIONAL CONSEQUENCES OF THE TAMPONADE. NO SERVICE NEEDED TO THE GENERATOR AND PUMP. PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE, POSSIBLY IN ADDITION TO PATIENT CONDITION. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTION WAS SUSPECTED OR OBSERVED.

  Patient problems: Cardiac Tamponade

  MAUDE report 19098502 ↗
• MalfunctionFeb 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND POST-PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A DAMAGE/SEPARATION AT THE TIP/SHAFT TRANSITION WITH EXPOSED COMPONENTS. DURING THE MAPPING WITH ABLATION CATHETER, THE PHYSICIAN TOOK THE CATHETER OUT OF THE PATIENT. UNDER THE ELECTRODES, THE CATHETER HAD DAMAGED. THE CATHETER WAS REPLACED AND THE PROCEDURE COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741717 ↗
• InjuryFeb 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND PATIENT EXPERIENCED A PROLONGED A-H INTERVAL AFTER ABLATION PROCEDURE AND REQUIRED EXTENDED HOSPITALIZATION. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING THAT TACHYCARDIA WAS NOT INDUCED. NO ADDITIONAL INTERVENTIONS. IT WAS REPORTED THE PATIENT WAS SCHEDULED TO BE DISCHARGED ON (B)(6), BUT THE HOSPITAL STAY WOULD BE EXTENDED UNTIL (B)(6) TO FOLLOW UP THE PATIENT'S CONDITION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS EVENT WAS THAT IT WAS PROCEDURE AND PATIENT CONDITION RELATED. THE SLOW PASSWAY LESION WAS CLOSE TO HIS (HIS BUNDLE). PATIENT OUTCOME WAS REPORTED TO BE IMPROVED.

  Patient problems: Arrhythmia

  MAUDE report 18736897 ↗
• InjuryDec 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A THERMOCOOL SMARTTOUCH SF ABLATION CATHETER EXPERIENCED CARDIAC ARREST AND REQUIRED HOSPITALIZATION. WHILE THE PHYSICIAN WAS ABLATING, HE HAD TERMINATED THE ARRHYTHMIA WITH VENTRICULAR TACHYCARDIA, BUT THE PATIENT BEGAN TO EXHIBIT LOW BLOOD PRESSURE THAT CONTINUED TO DROP. NO EVIDENCE OF STEAM POP. THE PATIENT FLAT-LINED AND WENT INTO CARDIAC ARREST. CONFIRMED THE ISSUE "WHILE LOOKING AT ICE (INTRACARDIAC ECHOCARDIOGRAPHY) AND REALIZING THE HEART WAS NOT CONTRACTING AND THERE WERE ECGS ON THE PATIENT." THE RECORDING SYSTEM SHOWED THE PATIENT GOING FROM VENTRICULAR TACHYCARDIA TO VENTRICULAR FIBRILLATION. PHYSICIAN PERFORMED CHEST COMPRESSIONS, MEDICINE WAS ADMINISTERED, THE PATIENT WAS SHOCKED WITH AN EXTERNAL DEFIBRILLATOR TWICE, AND THE PATIENT WAS FINALLY SHOCKED WITH HIS PACEMAKER SUCCESSFULLY. THE PATIENT WAS ALSO INTUBATED AND HIS HEART RATE BECAME STABLE AND THE VENTRICULAR TACHYCARDIA LEFT. PATIENT WAS HYPOTHERMIC, NOT RESPONSIVE IMMEDIATELY AFTER RESUSCITATION AND REMAINED INTUBATED FOR REST OF THE DAY. NO CARDIAC TAMPONADE OCCURRED AND THE PATIENT REQUIRED PROLONGED HOSPITALIZATION

  Patient problems: Cardiac Arrest

  MAUDE report 18253774 ↗
• MalfunctionNov 30, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER. DURING THE PROCEDURE, TIP OF THE CATHETER WAS CLOGGED ALTHOUGH SALINE WAS GONE. FLUID SETTINGS; <30W; 8 AND >30W; 15. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 06-NOV-2023. THERE WAS NO WARNING FROM THE PUMP. THERE WAS AN IMPEDANCE RISE WHEN THEY TRIED TO ABLATE. THE CALLER ASKED THE PHYSICIAN TO TAKE THE CATHETER OUT IMMEDIATELY. THE CALLER GAVE BOLUS IRRIGATION, BUT NO FLUID CAME OUT OF THE HOLES. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 06-NOV-2023 THAT THE CATHETER WAS BEING USED ON THE PATIENT WHEN THE IRRIGATION ISSUE OCCURRED AND HAVE REASSESSED THE EVENT AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18235233 ↗
• InjuryNov 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ARTICLE WAS RECEIVED ENTITLED "50W VS 40W DURING HIGH-POWER SHORT-DURATION ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION" THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: COSTEA A, DIAZ JC, OSORIO J, MATOS CD, HOYOS C, GOYAL S, TE C, D'SOUZA B, RASTOGI M, LOPEZ-CABANILLAS N, IBANEZ LC, THORNE C, VARLEY AL, ZEI PC, SAUER WH, ROMERO JE. 50W VS 40W DURING HIGH-POWER SHORT-DURATION ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION: A MULTICENTER PROSPECTIVE STUDY. JACC CLIN ELECTROPHYSIOL. 2023 SEP 5:S2405-500X(23)00618-7. DOI: 10.1016/J.JACEP.2023.08.005. EPUB AHEAD OF PRINT. PMID: 37804258. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND HIGH-POWER SHORT-DURATION (HPSD) RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION (AF) INCREASES FIRST-PASS PULMONARY VEIN ISOLATION (PVI) AND FREEDOM FROM ATRIAL ARRHYTHMIAS WHILE DECREASING PROCEDURAL TIME. HOWEVER, THE OPTIMAL POWER SETTING IN TERMS OF SAFETY AND EFFICACY HAS NOT BEEN DETERMINED. OBJECTIVES THIS STUDY COMPARED THE PROCEDURAL CHARACTERISTICS AND CLINICAL OUTCOMES OF 50W VS 40W DURING HPSD ABLATION OF PAROXYSMAL AF. METHODS PATIENTS FROM THE REAL-AF PROSPECTIVE MULTICENTER REGISTRY (REAL-WORLD EXPERIENC

  Patient problems: Heart Failure/Congestive Heart Failure; Pericardial Effusion; Pericarditis

  MAUDE report 18211843 ↗
• InjuryNov 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER AND THE PATIENT SUFFERED A CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS. THE EFFUSION WAS DETECTED DIRECTLY AFTER THE PROCEDURE. PUNCTION WAS DONE AND PATIENT WAS FINE AFTER LEAVING THE LAB. 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 18167485 ↗
• InjuryOct 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A IDIOPATHIC VT CARDIAC ABLATION PROCEDURE UTILIZING A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION AND CARDIAC HEMATOMA AND REQUIRED HOSPITALIZATION FOR FURTHER EVALUATION. DURING THE PROCEDURE WHILE UTILIZING THE ABLATION CATHETER IN THE LEFT VENTRICLE, THE CATHETER PERFORATED INTO THE RIGHT ATRIUM DISCOVERED BY UTILIZING THE SOUNDSTAR CATHETER. THE INTRACARDIAC ECHO SHOWED A HEMATOMA WITHIN THE HEART AND THE TRANSESOPHAGEAL ECHO CONFIRMED THE HEMATOMA. THE CARDIAC SURGERY TEAM ARRIVED IN THE ROOM AND, AFTER APPROXIMATELY 20 MINUTES, THE HEMATOMA WAS EVALUATED AND DID NOT APPEAR TO BE GETTING LARGER. THE PATIENT REMAINED STABLE AND WAS TAKEN TO COMPUTED TOMOGRAPHY (CT) TO COMPLETE A SCAN. ANTICOAGULANTS WERE STOPPED AND NO FURTHER INTERVENTION WAS PERFORMED BEYOND DISCONTINUATION OF THE PROCEDURE AND SUBSEQUENT CT SCAN. PHYSICIAN'S OPINION ON CAUSE OF THE EVENT IS PATIENT CONDITION. PATIENT HAS EBSTEIN CONGENITAL HEART DEFECT ANOMALY AND THIS PROCEDURE AND THIS WOULD BE THE 7TH CARDIAC PROCEDURE BESIDES OTHER RELEVANT MEDICAL HISTORY. CORRECT SETTINGS SELECTED ON DEVICES, AND NO ERROR MESSAGES ON EQ

  Patient problems: Cardiac Perforation; Hematoma

  MAUDE report 17998866 ↗
• MalfunctionSep 14, 2023Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED METAL BRAID EXPOSED ON THE SHAFT. INITIALLY AFTER CONNECTING THE CATHETER TO THE PATIENT INTERFACE UNIT (PIU) FOR AFIB-ABLATION, THE ERROR 105 OCCURRED. TROUBLESHOOTING WAS DONE. CABLE WAS CHANGED, AT LEAST THE CATHETER NO1 AND NO2 WAS CHANGED. THE PROCEDURE STARTED AND FINISHED SUCCESSFULLY WITH THE CATHETER. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. IT WAS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THE ERROR 105 WAS ASSESSED AS NON MDR REPORTABLE. THE INCIDENCE OF MAGNETIC SENSOR ERROR WAS EASY DETECTABLE BY THE USER. THE CATHETER WAS INOPERABLE SINCE IT CANNOT BE VISUALIZED ON THE CARTO SYSTEM. THE USER WILL HAVE TO REPLACE THE CATHETER. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17747542 ↗

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