NaviStar ThermoCool NI75TCFHRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10846835000566), received between Dec 30, 2016 and Sep 23, 2026 — classified as 14 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (6 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 36 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that during a clinical study Atrial Fibrillation (AFIb) case, the patient suffered complete heart block requiring surgical intervention. Patient received an index cardiac ablation for ventricular tachycardia. On (b)(6) 2026, patient experienced complete heart block (AE#1), categorized as moderate and serious, defined by hospitalization with an admission date of (b)(6) 2026 and a discharge date of (b)(6) 2026. Relationship to study device is probable (NAVISTAR THERMOCOOL AND OPTRELL CATHETERS) and relationship to the index study procedure is probable. The adverse event is anticipated. The outcome is resolved with an end date of (b)(6) 2026. Intervention was surgery (Upgrade to a CRT-D "[Cardiac Resynchronization Therapy Defibrillator]" System. Patient had already a 1 Chamber -ICD "[Implantable Cardioverter-Defibrillator]").

  Patient problems: Heart Block

  MAUDE report 50871199 ↗
• MalfunctionNov 24, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR THERMOCOOL CATHETER AND THE MEDICAL TEAM FOUND INTERMITTENT OR LOW IRRIGATION ON THE DEVICE BUT NOT COMPLETE OCCLUSION. NO ERROR MESSAGES WERE NOTED PRIOR TO THE ISSUE. THE ISSUE WAS DISCOVERED SINCE THE TEMPERATURE ABNORMALLY INCREASED, RESULTING IN THE INABILITY TO DISCHARGE. AFTER REMOVING THE CATHETER FROM THE PATIENT'S BODY, THE SURGEON OPENED THE THREE-WAY VALVE AND ACTIVATED THE FAST-FLUSHING FUNCTION OF THE PUMP AND FOUND THAT THE CATHETER TIP COULD NOT RELEASE WATER. THE THREE-WAY VALVE CAN DISCHARGE WATER, SO IT IS DETERMINED THAT THERE IS A PROBLEM WITH THE PIPELINE. THE CORRECT SETTINGS WERE SELECTED ON THE GENERATOR. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23635923 ↗
• MalfunctionMar 7, 2025Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE WAS NOT FLUSHING CORRECTLY. THE ISSUE WAS NOTED AFTER THE MEDICAL TEAM HAD STARTED THE FIRST ABLATION. SOME OF THE IRRIGATION HOLES FELT LIKE THEY WERE PLUGGED. THEY REMOVED THE CATHETER FROM THE PATIENT'S BODY AND NOTED THAT THREE OF THE IRRIGATION HOLES WERE CLOGGED AND NOT FLUSHING PROBABLY. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS ALSO SET CORRECTLY AS WELL. HOWEVER, THE TEMPERATURE ROSE AS SOON AS ABLATION STARTED. 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 21551359 ↗
• InjuryFeb 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PVC (PREMATURE VENTRICULAR CONTRACTION) ABLATION WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED A CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. CARDIAC TAMPONADE OCCURRED DURING LVOT (LEFT VENTRICULAR OUTFLOW TRACT) PVC ABLATION. NO CARDIAC SURGERY WAS NECESSARY. THE PERICARDIAL EFFUSION STOPPED AFTER PERICARDIAL PUNCTURE. PATIENT FULLY RECOVERED. PROCEDURE DETAILS INCLUDE: TEMPERATURE CONTROLLED MODE, 40W. 3 LESIONS, MAX. ABLATION TIME 43S, MAX. TEMPERATURE 39°C. INITIAL MAX. IMPEDANCE 229OHM, NO ABRUPTLY DROP/RISE BUT MAX. DROP OF 67OHM OVER 10S. THERE WAS NO EVIDENCE OF STEAM POP.

  Patient problems: Cardiac Tamponade

  MAUDE report 21349602 ↗
• MalfunctionAug 12, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB REVEALED THAT THE PEEK HOUSING WAS BROKEN LEAVING INTERNAL PARTS EXPOSED. DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958963 ↗
• MalfunctionJul 3, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND A SMARTABLATE¿ IRRIGATION TUBING SET. IT WAS NOTED THAT THE ¿TUBING KINKING RESULTS IN CLOTS IN THE ABLATION CATHETER¿. THE TUBING SET AND THE ABLATION CATHETER WERE REPLACED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO CHAR, ONLY CLOT. THERE WAS A PUMP ERROR, AND THEY NOTICED A KINK ON THE TUBE AND A LOT OF CLOT IN THE CATHETER. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. HEPARINIZED NORMAL SALINE WAS USED AS THE IRRIGATION FLUID. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670715 ↗
• MalfunctionJun 13, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PVC PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE CURVE WAS STUCK/JAMMED IN A DEFLECTED POSITION. INITIALLY A DEFLECTION ISSUE WAS REPORTED. BEFORE THE PROCEDURE, WHEN DEFLECTING THE CATHETER, THE CATHETER WAS OVER-DEFLECTED (AS THE PHOTO SHOWS). THE CURVE WAS ABNORMAL. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 21-MAY-2024. THE CURVE OF THE CATHETER WAS STUCK/JAMMED IN A DEFLECTED POSITION. THE KNOB/PISTON WAS UNABLE TO BE TURNED AND/OR PUSHED UP AND DOWN. THERE WAS DIFFICULTY IN REMOVING THE CATHETER FROM THE PATIENT. THERE WAS NO RING, ELECTRODE OR OTHER PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER. ADDITIONAL INFORMATION REQUESTED TO CLARIFY THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE THAT THE CURVE OF THE CATHETER WAS STUCK/JAMMED IN A DEFLECTED POSITION ON 21-MAY-2024 AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 21-MAY-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534182 ↗
• MalfunctionMar 26, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PVC PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE PEEK HOUSING WAS BROKEN WITH INTERNAL COMPONENTS EXPOSED. INITIALLY A DEFLECTION ISSUE WAS REPORTED. DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2024, THE PEEK HOUSING WAS BROKEN WITH INTERNAL COMPONENTS EXPOSED. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE PEEK HOUSING WAS BROKEN WITH INTERNAL COMPONENTS EXPOSED ON (B)(6) 2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978670 ↗
• MalfunctionNov 30, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND BLOOD RAN BACK INTO THE IRRIGATION SUPPLY LINE. THE MEDICAL TEAM BELIEVED THAT THERE WAS PRESSURE BUILT UP WITHIN THE SUPPLY LINE, SO MUCH SO THAT THE IRRIGATION TUBE CAME OFF. ACCORDING TO THE NURSING STAFF, THE ABLATION CATHETER WAS FLUSHED BEFOREHAND AND EVERYTHING WAS WITHIN THEIR EXPECTED STANDARD. THE PUMP WAS PROBABLY ALSO RUNNING WHILE THE CATHETER WAS IN THE PATIENT. THE PHYSICIAN THEN NOTICED THE ISSUE WHEN THEY STARTED TO ABLATE. THE PHYSICIAN SAW BLOOD RUNNING INTO THE CATHETER. THE CATHETER COULD NO LONGER BE FLUSHED THROUGH. IT IS UNKNOWN IF THE NURSE STAFF USED HAPARIN FOR THE IRRIGATION SOLUTION OR IF THEY USED HEPARIN IN GENERAL, BUT THE PROCEDURE WAS PERFORMED IN THE LEFT ATRIUM. SO, ACCORDING TO STANDARD GUIDELINES, HEPARIN SHOULD HAVE BEEN USED. ADDITIONALLY, A BWI GENERATOR WAS NOT USED IN THIS PROCEDURE--A COMPETITOR'S GENERATOR AND PUMP WERE USED INSTEAD, THEREFORE, IT CANNOT BE CONFIRMED IF THE PROPER SETTINGS WERE USED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18240548 ↗
• MalfunctionNov 7, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER STERILIZATION PACKAGE HAD BEEN BROKEN. PRIMARY PACKAGE DAMAGED. IT WAS REPORTED THAT OUR DISTRIBUTOR ¿(B)(4)¿ DID INCOMING GOODS CHECKING, OPENED THE OUTER BOX (OUTER BOX WAS INTACT). IT WAS FOUND THAT THE STERILIZATION PACKAGE HAD BEEN BROKEN. NO SURGERY WAS INVOLVED. NO REPORT ON ANY PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088574 ↗
• MalfunctionAug 9, 2023Crack; Positioning Problem; Crack; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND POST-PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED THAT THE PEEK HOUSING WAS CRACKED WITH INTERNAL PARTS EXPOSED. DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17495485 ↗
• MalfunctionApr 21, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A CRACK THE PEBAX WHICH EXPOSED INTERNAL COMPONENTS. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER¿S REPORTED DEFLECTION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT THIS COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. ON (B)(6) 2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE TIP WAS BENT, AND THE PEEK HOUSING WAS CRACKED WITH EXPOSED INTERNAL PARTS. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF A ¿CRACK¿ IN THE PEBAX IS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788331 ↗
• MalfunctionFeb 23, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT( ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, THE SIGNAL INTERFERENCE NOISE WAS OBSERVED ON IC, BS, OR ALL ECG (BS + IC) CHANNELS. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE CUSTOMER¿S REPORTED SIGNAL INTERFERENCE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE RISK TO THE PATIENT IS LOW. ON 27-JAN-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE PEEK HOUSING WAS DAMAGED. MICROSCOPIC EXAMINATION FOUND EVIDENCE OF A HOLE, STRESS MARKS AND MECHANICAL DAMAGE WITH INTERNAL COMPONENTS ARE EXPOSED. THIS FINDING WAS REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAD BEEN COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16425341 ↗
• MalfunctionJul 29, 2022Device-Device Incompatibility; Material Protrusion/Extrusion; Device-Device Incompatibility; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND AN ELECTRODE WAS DAMAGED WITHOUT FOREIGN MATERIAL WITH SHARP/ROUGH EDGES. DURING THE PROCEDURE, THE CATHETER COULD NOT ADVANCE IN THE SHEATH DUE TO THE IMPEDIMENT. ANOTHER VIZIGO SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON ADVERSE EVENT ON PATIENT. THE EVENT WAS ASSESSED AS A NOT MDR REPORTABLE FOR A ¿RESISTANCE WITH SHEATH¿ ISSUE. INTERFERENCE OR FRICTION BETWEEN DEVICES IS A KNOWN OCCURRENCE. IF RESISTANCE IS ENCOUNTERED, THE SYSTEM MAY BE WITHDRAWN AS A UNIT. THIS IS A COMMON PRACTICE DURING PROCEDURES. SINCE THE VAST MAJORITY OF EP PROCEDURES UTILIZE MULTIPLE DEVICE EXCHANGES, AN INCREASED POTENTIAL FOR PATIENT INJURY WAS REMOTE. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JUL-2022. THE MIDDLE OF THE SECOND AND THIRD ELECTRODE OF THE CATHETER WAS UNEVEN AND SCRATCHED, MAKING THE THIRD AND FOURTH ELECTRODES STUCK AND BEING UNABLE TO ADVANCE IN THE SHEATH. IT WAS CLARIFIED THAT NO VIZIGO SHEATH WAS USED DURING THE PROCEDURE. ANOTHER CATHETER WAS USED TO COMPLETE THE SURGERY, NOT SHEATH. THEY WERE INSERTING THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127368 ↗
• MalfunctionJan 11, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED THAT THE PEEK HOUSING WAS CRACKED WITH INTERNAL PARTS EXPOSED. INITIALLY, IT WAS REPORTED THAT DURING THE SVT OPERATION, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE DEFLECTION ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND A VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THE PEEK HOUSING TO BE CRACKED WITH INTERNAL PARTS EXPOSED. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 12/15/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225150 ↗
• MalfunctionJul 19, 2021Positioning Problem; Positioning Problem

  A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A NAVISTAR THERMOCOOL FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED A BROKEN TIP WITH INTERNAL PARTS EXPOSED. THE FINDING WAS IDENTIFIED ON (B)(6) 2021. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE PVC OPERATION, CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE DEFLECTION ISSUE IS NOT MDR-REPORTABLE. THE BROKEN TIP IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12191629 ↗
• InjuryNov 18, 2020High Readings; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; High Readings; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A VENTRICULAR EXTRASYSTOLE (VES) ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. AFTER CONFIRMATION WITH INTRACARDIAC SIGNALS THAT THE VES WERE COMING FROM THE LEFT VENTRICLE, THE PHYSICIAN DECIDED TO PERFORM A TRANSSEPTAL ACCESS TO GO IN THE LEFT VENTRICLE. AFTER USUAL TRANSSEPTAL PUNCTURE, THE PHYSICIAN INSERTED THE FIXED SHEATH ACROSS THE PUNCTURE, REMOVED THE NEEDLE AND THEN INSERTED THE ABLATION CATHETER THROUGH THE NEEDLE. EVERYTHING SEEMED NORMAL, WITH GOOD SIGNALS MEASURES; THEREFORE, THE PHYSICIAN DECIDED TO START THE MAPPING OF THE VES. AFTER APPROXIMATELY 10 MIN, THE PHYSICIAN NOTICED UNUSUALLY HIGH IMPEDANCE VALUE ON THE CATHETER. THE IMPEDANCE WAS ABOVE THE CUT-OFF VALUE; HOWEVER, SINCE NO ABLATION WAS INTENDED, THE SYSTEM DID NOT HAVE TO STOP ANY ABLATION. PERICARDIAL EFFUSION WAS THEN CONFIRMED BY INTRACARDIAC ECHOGRAPHY (ICE). CARDIAC TAMPONADE PROTOCOL WAS LAUNCHED AND PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE BLOOD FROM THE PERICARDIAL SPACE. AFTER APPROXIMATELY 1 HOUR DRAINING THE BLOOD AND REINJECTI

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 10864974 ↗
• MalfunctionSep 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER WHERE TIP WAS FOUND BROKEN AND SHAFT BENT NEAR THE HANDLE. IT WAS REPORTED THAT BEFORE THE SVT OPERATION, THE TIP OF THE NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER WAS FOUND BROKEN WITH EXPOSED WIRES AND THE SHAFT ON THE CATHETER NEAR HANDLE WAS BENT WITHOUT EXPOSED WIRES. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. DEVICE WAS NOT USED IN PATIENT. HANDLE WAS FOUND NOT FIXED IN ITS PLACE WHEN PHYSICIAN OPENED THE PACKAGE. ON 8/28/2020, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL INSPECTION FOUND THE TIP WAS BROKEN. NO DAMAGE ON ELECTRODES AND SHAFT WERE OBSERVED. THESE FINDINGS WERE REVIEWED AND DETERMINED THE EVENT CONTINUES TO BE MDR REPORTABLE FOR THE BROKEN TIP. THE CUSTOMER¿S REPORTED ISSUES OF BENT SHAFT AND BROKEN HANDLE ARE NOT MDR REPORTABLE SINCE THE POTENTIAL THAT THESE COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10486090 ↗
• MalfunctionJul 29, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE CATHETER WAS REPORTED TO HAVE INTERNAL WIRES EXPOSED. IT WAS REPORTED THAT THE NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER WAS PHYSICALLY BROKEN, THE SHAFT WAS DESTROYED, AND INTERNAL WIRES WERE EXPOSED. NO SHARP/LIFTED ELECTRODES WERE OBSERVED. THE CATHETER WAS NOT PRE-SHAPED. THE CATHETER WAS NOT INSIDE THE PATIENT WHEN THE ISSUE OCCURRED. IT WAS BEING USED WITH A PREFACE SHEATH NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339427 ↗
• MalfunctionMar 2, 2020Crack; Crack

  IT WAS REPORTED THAT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB IDENTIFIED A CRACK IN THE PEEK HOUSING WITH INTERNAL WIRES EXPOSED. INITIALLY IT WAS REPORTED THAT DURING THE PROCEDURE, IMPEDANCE COULD NOT BE DISPLAYED. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE WAS REPORTED. THE NO IMPEDANCE ISSUE WAS ASSESSED AS A NOT REPORTABLE ISSUE, SINCE THE IMPEDANCE IS NOT DISPLAYED, THE DEVICE CAN¿T BE USED. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH IS REMOTE. ON JANUARY 22, 2020, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION, AND UPON INITIAL VISUAL INSPECTION IT WAS NOTED THAT THE PRODUCT REVEALED NO PHYSICAL DAMAGE. ON FEBRUARY 5, 2020, AFTER FURTHER ANALYSIS AND TESTING, IT WAS FOUND THAT THE PEEK HOUSING WAS CRACKED WITH INTERNALS PARTS EXPOSED. THIS EVENT WAS ORIGINALLY CONSIDERED NOT MDR REPORTABLE, HOWEVER, BIOSENSE WEBSTER, INC. BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH SECOND VISUAL ANALYSIS ON FEBRUARY 5, 2020 A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774998 ↗
• InjurySep 23, 2019Adverse 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 WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ALL THE PROCEDURE, THE PATIENT¿S BLOOD PRESSURE WAS CONSIDERABLY LOW. POST-ABLATION PHASE, AT THE END OF THE PROCEDURE, CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF BLOOD FROM THE PERICARDIAL SPACE. SURGICAL INTERVENTION WAS NOT REQUIRED. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME WAS FULLY RECOVERED WITH NO RESIDUAL EFFECTS. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS BOTH PROCEDURE AND PATIENT CONDITION RELATED. NO BIOSENSE WEBSTER INC. (BWI) PRODUCT MALFUNCTIONS WERE REPORTED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH MULLINS AND BROKENBROUGH TRANSSEPTAL NEEDLE FROM MEDTRONIC. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. THE FLOW WAS SET AT LOW FLOW: 2 ML/MIN AND HIGH FLOW: 30 ML/MIN. NO ERROR MESSAGES WERE OBSERVED ON ANY BWI EQUIPMENT. THE FORCE VISUALIZATION FEATURES USED INCLUDED DASHBOARD, VECTOR AND VISITAG. THE PARAMETERS FOR STABILITY USED

  Patient problems: Cardiac Tamponade

  MAUDE report 9107886 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH HISTORY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) IMPLANTATION DUE TO VENTRICULAR TACHYCARDIA (VT) AND CARDIOPULMONARY RESUSCITATION (CPR), UNDERWENT AN EPICARDIAL/ENDOCARDIAL PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. THE PHYSICIAN FIRST PERFORMED THE EPICARDIAL PUNCTURE. THE PHYSICIAN THEN PUNCTURED THE GROIN FOR PLACEMENT OF BOTH ENDOCARDIAL RIGHT VENTRICLE RV CATHETER AND AN ABLATION CATHETERS. THE RV CATHETER WAS PLACED THROUGH A SHORT 7FR SHEATH AND INTO THE RV. THE ABLATION CATHETER WAS PLACED IN THE FEMORAL ARTERY THROUGH AN 8 FR LONG (ARROW) SHEATH. MAPPING WAS PERFORMED IN THE AORTA AND IN THE LEFT VENTRICLE (LV). MAPPING WAS PERFORMED TO THE EARLIEST ACTIVATION POINT AND ABLATION WAS COMPLETED. THE ARRHYTHMIA THEN STOPPED. THERE WAS A WAITING PERIOD AND AFTER 20 MINUTES AFTER THE START OF THE PROCEDURE, THE PHYSICIAN NOTICED A SUBSTANTIAL AMOUNT OF MEDIUM-DARK BLOOD COMING FROM THE EPICARDIAL SITE. THE PATIENT¿S BLOOD PRESSURE DECLINED, AND CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED T

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 8789718 ↗
• MalfunctionMay 6, 2019No Pacing; No Pacing

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND A PACING PROBLEM AFFECTED EMERGENCY PACING. IT WAS INITIALLY REPORTED THAT THEY WERE UNABLE TO PACE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE PACING ISSUE DESCRIBED WAS ASSESSED AS NOT REPORTABLE. THE CATHETER WOULD NEED TO BE REPLACED SINCE IT WAS NOT ABLE TO PACE FOR STIMULATION. THERE WOULD BE NO RISK TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 8, 2019 ON THE EVENT. THE PACING LEADS WERE CONNECTED TO THE PRIMARY PACING PORT. THE EP4 PACING STIMULATOR WAS BEING USED DURING THE PROCEDURE. THERE WAS NO UNWANTED PACING BEING DELIVERED. THE PACING PROBLEM AFFECTED BOTH ROUTINE AND EMERGENCY PACING. THERE WAS NO PATIENT CONSEQUENCE REPORTED. BASED ON THE ADDITIONAL INFORMATION STATING THAT THE PACING PROBLEM ALSO AFFECTED EMERGENCY PACING, THIS PACING ISSUE HAS BEEN RE-ASSESSED TO MDR REPORTABLE. THE AWARENESS DATE IS APRIL 8, 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8584144 ↗
• InjuryApr 25, 2019Adverse 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 ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH TWO NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CEREBROVASCULAR ACCIDENT (CVA) REQUIRING NO INTERVENTIONS BUT EXTENDED HOSPITALIZATION. THE PROCEDURE WAS CARRIED OUT AS USUAL AND HAD A PHASE OF MAPPING, ABLATION AND CARDIOVERSION. THE PATIENT WAS UNDER GENERAL ANESTHESIA. WHEN THE PATIENT WAS AWAKENED FROM THE ANESTHESIA, THE PHYSICIAN OBSERVED MUSCULAR NUMBNESS. THE PATIENT HAD DEVELOPED A CEREBRAL EMBOLISM. NO MEDICAL/SURGICAL INTERVENTION WAS PROVIDED; HOWEVER, EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE PHYSICIAN WAS UNSURE ON WHETHER THE ADVERSE EVENT WAS RELATED TO THE PROCEDURE OR PATIENT¿S CONDITION. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS WERE REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 8553344 ↗
• InjuryApr 25, 2019Adverse 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 ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH TWO NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CEREBROVASCULAR ACCIDENT (CVA) REQUIRING NO INTERVENTIONS BUT EXTENDED HOSPITALIZATION. THE PROCEDURE WAS CARRIED OUT AS USUAL AND HAD A PHASE OF MAPPING, ABLATION AND CARDIOVERSION. THE PATIENT WAS UNDER GENERAL ANESTHESIA. WHEN THE PATIENT WAS AWAKENED FROM THE ANESTHESIA, THE PHYSICIAN OBSERVED MUSCULAR NUMBNESS. THE PATIENT HAD DEVELOPED A CEREBRAL EMBOLISM. NO MEDICAL/SURGICAL INTERVENTION WAS PROVIDED; HOWEVER, EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THE PHYSICIAN WAS UNSURE ON WHETHER THE ADVERSE EVENT WAS RELATED TO THE PROCEDURE OR PATIENT¿S CONDITION. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS WERE REPORTED.

  Patient problems: Stroke/CVA

  MAUDE report 8553343 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031. One submission often covers many models, so check the product and lot details in each record.

• Z-0169-2023 · Sep 7, 2022 · Open, Classified
  THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in con
• Z-0139-2015 · Oct 19, 2014 · Terminated
  ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
• Z-0982-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-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-0979-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0983-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0057-06 · Aug 8, 2005 · Terminated
  Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R P