ThermoCool SF NAV BNI35DFHRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10846835003215), received between Jun 16, 2016 and Nov 7, 2025 — classified as 1 death, 13 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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, 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT A PVC WITH OCTARAY (2-2-2) AND AN THERMOCOOL SF CATHETER WAS PERFORMED. THE EARLIEST SITE OF ABLATION WAS TOO CLOSE TO THE HIS-PURKINJE SYSTEM TO ABLATE; THEREFORE, NO ABLATION WAS PERFORMED. IMMEDIATELY AFTER THE CASE, THE PATIENT DID NOT LOOK TOO WELL, AND THE PHYSICIANS CHECKED THE BLOOD PRESSURE, SYSTOLIC PRESSURE WENT DOWN TO 56MMHG. TWO HOURS LATER, THE PATIENT PRESENTED WITH A TAMPONADE. INTERVENTION WAS A PERICARDIAL PUNCTURE. THE ADVERSE EVENT OCCURRED ON (B)(6) 2023. IT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER INC. (BWI) PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE AND BWI PRODUCT RELATED. THE PATIENT FULLY RECOVERED (NO RESIDUAL EFFECTS). IT WAS INDICATED THAT THE PATIENT PROBABLY REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT WITH DETAILS UNKNOWN. RELEVANT TESTS/LABORATORY DATA-TESTS REVEALED THAT THE TAMPONADE WAS RIGHT-SIDED (S

  Patient problems: Cardiac Tamponade

  MAUDE report 16993359 ↗
• MalfunctionOct 12, 2022Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER WHEREIN PRODUCT STERILITY WAS COMPROMISED. IT WAS REPORTED THE PACKAGING OF THE CATHETER WAS RIPPED, SO THE CATHETER WASN¿T STERILE ANYMORE. THEY HAD TO OPEN A NEW ONE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION RECEIVED INDICATED THE CARDBOARD PACKAGING WAS OKAY BUT THE INNER PACKAGING (WHITE BACK AND CLEAR FRONT) WAS TORN OPEN. THERE WAS NO DAMAGE TO THE POUCH SEAL PER SE BUT IT LOOKED LIKE SOMEONE OPENED IT BEFORE. THE CATHETER WAS NOT USED ON THE PATIENT BECAUSE IT WASN¿T STERILE ANYMORE. IT LOOKED FINE THOUGH, SO NO OBVIOUS DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592763 ↗
• InjurySep 13, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED HEART BLOCK REQUIRING A TEMPORARY PACEMAKER. AFTER CARDIOVERSION (DC), SINUS DID NOT APPEAR WITH THE THERMOCOOL SF CATHETER. PULMONARY VEIN ISOLATION (PVI) PLUS LINE ABLATION WAS PERFORMED IN LONG-STANDING PERSISTENT AF (LSAF) PROCEDURE AND AFTER THAT, DC WAS PERFORMED, BUT SINUS DID NOT COME OUT. THE PATIENT LEFT THE ROOM WITH TEMPORARY PACING. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS IMPROVED. THERE WAS NO REPORT THAT EXTENDED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN COMMENTED THAT "SINCE IT WAS SSS AT THE LAST TIME SINUS WAS CONFIRMED," THE SINUS HAS NOT COME OUT ALREADY FROM THE TIME OF ENTERING THE ROOM, AND IT MAY BE UNRELATED TO THE PROCEDURE. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED. THE PHYSICIAN THOUGHT THAT SINCE THE PATIENT HAS SICK SINUS SYNDROME AT THE LAST TIME SINUS RHYTHM WAS CONFIRMED, THE PATIENT ALREADY HAS SICK SINUS FROM THE TIME OF ADMISSION, AND

  Patient problems: Heart Block

  MAUDE report 12464078 ↗
• InjuryOct 7, 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 WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). BEFORE THE PROCEDURE STARTED, BUBBLE ERROR OCCURRED WITH THE SMARTABLATE¿ IRRIGATION TUBING SET. THE TUBING WAS FLUSHED, AND THE PUMP WAS CLEANED AND REBOOTED, BUT THE ISSUE REMAINED. THE ISSUE WAS RESOLVED BY REPLACING THE TUBING. THIS ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THERE IS NO RISK TO THE PATIENT AS A RESULT OF THE PROCEDURE DELAY. THE PROCEDURE CONTINUED, ATRIAL TACHYCARDIA (AT) WAS MAPPED AND REFERENCE WAS INSERTED INTO THE LEFT ATRIAL APPENDAGE (LAA) A RING CATHETER WAS USED AND REPEATEDLY MOVED INSIDE THE LAA DUE TO THE DEVIATION OF THE REFERENCE. ABLATION WAS THEN STARTED. AFTER THE FIRST ABLATION NEAR THE BASE OF THE LAA, THE PATIENT¿S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS CONFIRMED BY ECHOCARDIOGRAPHY. REMINDER OF THE PROCEDURE WAS ABORTED. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE FLUID FROM THE PERICARDIAL SPACE; HOWEVER, PATIENT¿S BLOOD PRESSURE DID NOT RESTORE, AND PCPS WERE PERFORMED. THE

  Patient problems: Cardiac Tamponade

  MAUDE report 10645275 ↗
• DeathMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REPEAT PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR AND SUFFERED ATRIOESOPHAGEAL FISTULA AND AIR EMBOLISM REQUIRING HOSPITALIZATION AND DEATH. A FEMALE PATIENT BORN IN (B)(6) UNDERWENT A REPEAT PULMONARY VEIN ISOLATION (PVI) USING THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND LASSO® NAV ECO VARIABLE CATHETER WITHOUT ANY PROBLEMS. THE PATIENT WAS SENT HOME AFTER UNCOMPLICATED PROCEDURE WITHOUT ANY KNOWN SIDE EFFECTS. PATIENT WAS HOSPITALIZED APPROX. 2 WEEKS AFTER THE PROCEDURE IN ANOTHER HOSPITAL DUE TO BREAST PAIN AND MALAISE. A COMPUTED TOMOGRAPHY (CT) SCAN DIDN¿T SHOW ANY CONSPICUOUSNESS. DURING THAT TIME THE PATIENT¿S CONDITION DETERIORATED SHOWED SIGNS OF WORSENING OUTCOME. GASTROSCOPY REVEALED ATRIA-ESOPHAGEAL FISTULA IN PATIENT. THE PATIENT DEVELOPED AIR EMBOLISM AND FISTULA WAS TREATED WITH CLIPS. PRESSURE CHAMBER TREATMENT WAS PERFORMED. PATIENT WAS IN INTENSIVE CARE AT THE MOMENT OF THE CALL IN VERY SERIOUS CONDITION WITH DIRE PROGNOSIS AND SUBSEQUENTLY EXPIRED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS TH

  Patient problems: Air Embolism; Death; Fistula; No Code Available

  MAUDE report 9891850 ↗
• InjuryAug 21, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER AND A MEDICAL DEVICE ENTRAPMENT OCCURRED THAT LED TO CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE CATHETER GOT JAMMED IN THE VENTRICLE STRUCTURE. THE PHYSICIAN UNJAMMED THE CATHETER BY MOVING THE SHEATH HIGHER. AT THIS TIME, THE CATHETER PERFORMED A SUDDEN MOTION AND PERFORATED. THE TRANSTHORACIC ECHOCARDIOGRAPHY (TEE) SHOWED BLOOD INSIDE THE PERICARDIUM. CARDIAC TAMPONADE WAS CONFIRMED, AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF BLOOD FROM THE PERICARDIAL SPACE. IT IS BELIEVED THAT EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE EVENT; HOWEVER, THIS INFORMATION WAS NOT CONFIRMED. PATIENT¿S OUTCOME IS UNKNOWN. THE PHYSICIAN DID NOT ATTRIBUTE THE CAUSALITY OF THE ADVERSE EVENT TO A BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTION. THE CATHETER MANIPULATION WAS NOT CONSIDERED EXCESSIVE. NO DAMAGE SUCH AS WIRES EXPOSED, OR LIFTED/SHARP RINGS WERE OBSERVED ON THE CATHETER. THE CATHETER WAS NOT PRE-SHAPED. NO FURTHER INFORMATION IS AVAILABLE. THE ISSUE OF STEAM POP WAS ASSESSED AS A N

  Patient problems: Cardiac Tamponade

  MAUDE report 8919277 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ABLATION PROCEDURE WITH AN THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE. POST-PROCEDURE, CARDIAC TAMPONADE WAS CONFIRMED. IT IS UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. EXTENDED HOSPITALIZATION WAS REQUIRED, AS A RESULT OF THE ADVERSE EVENT. THE PHYSICIAN DID NOT ATTRIBUTE THE CAUSALITY OF THE EVENT TO A BIOSENSE WEBSTER INC. (BWI) PRODUCT. ON POST-PROCEDURE DAY 8, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Cardiac Tamponade

  MAUDE report 8340706 ↗
• MalfunctionAug 17, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER. A THROMBUS FORMATION WAS OBSERVED ON THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER TIP. THERE WERE NO PATIENT CONSEQUENCES. THERE IS NO EVIDENCE OF NEUROLOGICAL SIGNS OR SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THERE IS NO INFORMATION REGARDING GENERATOR PARAMETERS OR GENERATOR SETTINGS. THERE WERE NO CATHETER ISSUES RELATED TO TEMPERATURE OR FLOW. SYSTEM DID NOT PRESENT ANY ERROR MESSAGES. PHYSICIAN DID NOT REPORT ANY PRODUCT PROBLEMS. THERE IS NO INFORMATION REGARDING ANTICOAGULANT BEING USED DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793731 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. WHILE MAPPING WITH THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER, THE PHYSICIAN ABRUPTLY MANEUVERED THE CATHETER TO ANOTHER LOCATION IN THE VENTRICLE. NO FORCE ISSUES WERE OBSERVED. TEN MINUTES LATER, THE PHYSICIAN NOTICED IMPAIRED CARDIAC MOVEMENT. PERICARDIAL EFFUSION WAS DETECTED VIA ULTRASOUND. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED VOLUME OF FLUID. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT OUTCOME. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. THERE WERE NO ERRORS OF ISSUES REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE IS NO SHEATH INFORMATION. THERE IS NO INFORMATION REGARDING GENERATOR PARAMETERS, GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TI

  Patient problems: Cardiac Tamponade

  MAUDE report 7453383 ↗
• InjuryMar 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IN THE MIDDLE OF THE PROCEDURE, THE PATIENT BECAME SLIGHTLY HYPOTENSIVE. A SMALL PERICARDIAL EFFUSION WAS DETECTED VIA ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED AND YIELDED AN UNSPECIFIED AMOUNT OF VOLUME. ONLY THE ABLATION PROBE WAS IN THE PATIENT¿S VENTRICLE. IT WAS NOTED THAT THE PHYSICIAN WAS UNABLE TO DETERMINE IF THE EFFUSION WAS SECONDARY TO CATHETER MANIPULATION OR ABLATION.

  Patient problems: Cardiac Tamponade

  MAUDE report 7355689 ↗
• InjuryFeb 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL SF NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE. DURING MAPPING IN THE RIGHT VENTRICLE, A PERFORATION OCCURRED. PATIENT FULLY RECOVERED. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THE PATIENT¿S CONDITION, SPECIFICALLY, THIN MYOCARDIAL TISSUE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO ABLATION WAS PERFORMED.

  Patient problems: Cardiac Tamponade

  MAUDE report 7248519 ↗
• InjuryApr 19, 2017Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH AN EZ STEER THERMOCOOL SF NAV CATHETER AND SUFFERED A RESPIRATORY INFECTION, A CEREBROVASCULAR ACCIDENT, AND AN ESOPHAGEAL FISTULA (REQUIRING AN ENDOSCOPIC CLIP AND AN ATRIO-ESOPHAGEAL PATCH). ABLATION WAS INITIALLY BEING CONDUCTED WITH A ¿HOT¿ BALLOON (BRAND UNSPECIFIED), BUT THE LEFT SUPERIOR PULMONARY VEIN (LSPV) AND RIGHT INFERIOR PULMONARY VEIN (RIPV) COULD NOT BE ISOLATED. RADIOFREQUENCY ABLATION WAS PERFORMED ON THE LSPV (7 O¿CLOCK POSITION) AND THE RIPV (5 O¿CLOCK POSITION). ESOPHAGEAL TEMPERATURE PROBE WAS USED AND ABLATION WAS STOPPED WHEN TEMPERATURE REACHED 40 DEGREES CELSIUS. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENTS THAT FOLLOWED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENTS IS THAT THEY WERE PROCEDURE-RELATED. APPROXIMATELY 3-4 WEEKS POST-PROCEDURE, THE PATIENT WAS ADMITTED FOR PNEUMONIA. TWO DAYS POST-ADMISSION, THE PATIENT WAS DIAGNOSED WITH BACTEREMIA. PHYSICIAN CONSIDERED THE POSSIBILITY OF AN ATRIO-ESOPHAGEAL FISTULA SECONDARY TO ABLATION. RIG

  Patient problems: Embolus; Fistula; Injury; Pneumonia; Respiratory Tract Infection; Stroke/CVA

  MAUDE report 6503633 ↗
• MalfunctionNov 3, 2016Sticking

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH AN EZ STEER THERMOCOOL SF NAV CATHETER WHERE CLOTTING WAS FOUND STUCK TO THE TIP. DURING THE PROCEDURE, IT WAS FOUND THAT THE CATHETER COULD NOT BE FLUSHED CORRECTLY. AN EXAMINATION OF THE CATHETER FOUND THAT THIS IS BECAUSE OF CLOTTING THAT HAD BECOME STUCK TO THE TIP. THE CATHETER WAS REPLACED WITH ANOTHER, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. THERE WERE NO ISSUES RELATED TO TEMPERATURE OR FLOW ON THE CATHETER. THE GENERATOR WAS BEING USED IN POWER CONTROL MODE, BUT THERE IS NO INFORMATION REGARDING THE POWER OR TEMPERATURE CUTOFF VALUES. IT WAS, HOWEVER, NOTED THAT NONE OF THE CUTOFF VALUES WERE REACHED. TEMPERATURE/POWER/IMPEDANCE VALUES AT THE TIME OF THE EVENT ARE UNKNOWN. AN ANTICOAGULANT WAS IN USE, BUT SPECIFIC INFORMATION IS NOT AVAILABLE. THE CLOTTING WAS NOT SPECIFICALLY IDENTIFIED AS CHAR/CLOT/COAGULUM BY THE PHYSICIAN. THE IRRIGATION/FLUSHING ISSUE IS NOT MDR REPORTABLE. HOWEVER, THE CLOTTING THAT CAUSED THE IRRIGATION/FLUSHING ISSUE IS MDR REPORTABLE. THOUGH THE CLOTTING SUBSTANCE WAS NOT IDENTIFIED, THIS EVENT IS BEING CONSERVATIVELY REPORTED, AS T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6077042 ↗
• MalfunctionAug 3, 2016High impedance

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND A CLOT WAS OBSERVED ON THE CATHETER. DURING THE ABLATION, A CLOT OR COAGULUM WAS OBSERVED IN CONJUNCTION WITH HIGH IMPEDANCE. THE SYSTEM DID STOP ABLATION WHEN THE HIGH IMPEDANCE CUT OFF VALUE WAS EXCEEDED. THERE WERE NO ERRORS REPORTED ON THE BIOSENSE WEBSTER SYSTEMS DURING THE PROCEDURE. IN ADDITION, THERE WERE NO ISSUES WITH TEMPERATURE OR FLOW ON THE CATHETER. THE GENERATOR WAS IN POWER MODE. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS EVENT IS MDR REPORTABLE BECAUSE CLOT/COAGULUM HAS POOR ADHERENCE TO CATHETERS AND TRANSSEPTAL SHEATHS AND IT COULD BE A POTENTIAL SOURCE OF EMBOLISM. THE HIGH IMPEDANCE ISSUE IS NOT MDR REPORTABLE BECAUSE THE GENERATOR STOPPED ABLATION, THEREFORE THE POTENTIAL THAT THE HIGH IMPEDANCE COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT IS REMOTE.

  Patient problems: Thrombus

  MAUDE report 5845528 ↗
• InjuryJun 16, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH AN EZ STEER THERMOCOOL SF NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION, UPON REMOVAL OF THE TRANSSEPTAL SHEATH, PATIENT BECAME HYPOTENSIVE AND TAMPONADE WAS CONFIRMED VIA ECHOCARDIOGRAM. PATIENT WAS STABILIZED AND TRANSFERRED TO THE CORONARY CARE UNIT. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. PATIENT WAS FULLY RECOVERED. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THE PATIENT'S COMPLEX ANATOMY AND THE PATIENT'S SEPTAL ANEURYSM. IT WAS ALSO NOTED THAT THE PHYSICIAN PERFORMED TWO TRANSSEPTAL PUNCTURES AND HAD TO REMOVE THE 2ND TRANSSEPTAL SHEATH, AS IT BECAME VERY UNSTABLE. PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO PATIENT CONDITION AND THE TRANSSEPTAL SHEATH. PHYSICIAN INDICATED THAT HE WAS CERTAIN THE TAMPONADE OCCURRED DURING THE 2ND TRANSSEPTAL PUNCTURE AND WAS NOT RELATED TO ABLATION OR THE ABLATION CATHETER. TRANSSEPTAL PUNCTURE PERFORMED WITH A ST. JUDE MEDICAL BRK-1 NEEDLE. GENERATOR PARAMETE

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 5731058 ↗