NaviStar RMT ThermoCool NR7TCSIYRecalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 10846835008500), received between Sep 8, 2016 and Dec 9, 2025 — classified as 9 deaths, 70 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (29 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 25 most recent of 103 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A NAVISTAR RMT THERMOCOOL ABLATION CATHETER AND THE PATIENT EXPERIENCED DROP IN BLOOD PRESSURE AND PERICARDIAL EFFUSION WAS TREATED WITH PERICARDIOCENTESIS. IT WAS REPORTED THAT AT THE END OF THE IDVT PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED ON THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGE. THERE WAS A DROP IN THE PATIENT'S BLOOD PRESSURE, AND THE EFFUSION WAS CONFIRMED ON ICE. PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN. THE PATIENT WAS NOW IN A STABLE CONDITION. INFORMATION RECEIVED INDICATED THE PERFORATION SITE WAS UNKNOWN. THE OUTCOME OF THE ADVERSE EVENT WAS THAT THE PATIENT FULLY RECOVERED. THE PROCEDURAL ACTIVATED CLOTTING TIME (ACT) DURING PROCEDURE WAS >350. THE SHEATH AND THE CATHETERS WERE EXCHANGED ONE TIME. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. THE NUMBER OF PERFORMED ABLATIONS WAS 11 WITH RADIOFREQUENCY (RF) ENERGY PERFORMED OUTSIDE THE PULMONARY VEINS. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH BSX VERSACROSS. NO EVIDENCE OF STEAM POP. THE EVENT OCCURRED IN THE POST ABLATION PHASE. THE FLOW SETTING WAS PER RECOMMENDED SETTI

  Patient problems: Cardiac Tamponade

  MAUDE report 23764712 ↗
• InjuryNov 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING CARDIAC ABLATION PROCEDURE WITH NAVISTAR RMT THERMOCOOL CATHETER, AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH DRAINAGE. IT WAS REPORTED THAT DURING THE PROCEDURE, THREE HOURS AFTER THE START OF THE PROCEDURE, CARDIAC TAMPONADE OCCURRED. THE PROCEDURE WAS COMPLETED WITH DRAINAGE PERFORMED, AND THE PROCEDURE WAS TERMINATED. NO EXTENDED HOSPITALIZATION WAS NOTED. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO/OR DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE ENERGY SOURCE USED WHEN THE ADVERSE EVENT OCCURRED WAS RADIOFREQUENCY (RF). ONE CATHETER WAS USED DURING THE PROCEDURE. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. THE ENERGY DELIVERED FOR EACH GROUP OF PERFORMED ABLATIONS WAS RADIOFREQUENCY (RF). THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. NO RELEVANT TESTS/LABORATORY DATA OR OTHER RELEVANT HISTORY/PRE-EXISTING CONDITION WAS NOTED. THE PROCEDURAL ACTIVATED CLOTTING TIME (ACT) WAS 329 SECONDS. THE NUMBER OF PERFORMED

  Patient problems: Cardiac Tamponade

  MAUDE report 23612899 ↗
• InjuryJul 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING IDIOPATHIC VENTRICULAR TACHYCARDIA - LEFT (L-IDVT) CARDIAC ABLATION PROCEDURE WITH A NAVISTAR RMT THERMOCOOL CATHETER, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE, PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS AND DRAINAGE TUBE PLACEMENT. THERE WAS A PERICARDIAL EFFUSION DISCOVERED DURING THE PROCEDURE. THERE WAS "A LOT OF ABLATIONS" PERFORMED DURING THE PROCEDURE. AT THE END OF THE PROCEDURE WHEN THE PHYSICIAN WAS "PULLING EVERYTHING OUT," THEY NOTICED THERE WAS A "SIGNIFICANT" PERICARDIAL EFFUSION PRESENT. THE EFFUSION WAS DISCOVERED AND CONFIRMED VIA INTRACARDIAC ECHO USING A SOUNDSTAR CATHETER. A BASELINE EFFUSION WAS NOT DOCUMENTED. THE SIZE OF THE EFFUSION DISCOVERED DURING THE PROCEDURE WAS NOT KNOWN. THE PATIENT¿S NONINVASIVE BLOOD PRESSURE WAS LOW, SYSTOLIC IN THE 80'S. A PERICARDIOCENTESIS WAS PERFORMED AND AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. THE DRAINAGE TUBE WAS REMOVED PRIOR TO THE PATIENT LEAVING THE EP LAB. THE PATIENT WAS STABLE AND TRANSFERRED TO THE CARDIAC CRITICAL CARE UNIT FOR OVERNIGHT OBSERVATION. ADDITIONAL INFORMATION IS NOT KNOWN AT THIS TIME. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT.

  Patient problems: Cardiac Tamponade

  MAUDE report 22618211 ↗
• InjuryJun 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR RMT THERMOCOOL AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED DRAINAGE. CARDIAC TAMPONADE WAS CONFIRMED AFTER THE PROCEDURE AND DRAINAGE WAS PERFORMED. ABOUT 500 ML WAS DRAWN WITH DRAINAGE. PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION. THERE WERE NO ABNORMALITIES PRIOR TO OR DURING USE OF THE PRODUCT. RELEVANT PAST MEDICAL HISTORY INCLUDE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (S-ICD) HAD BEEN IMPLANTED DUE TO BRUGADA SYNDROME. REPORTED LABORATORY TEST AND RESULTS INCLUDE CORONARY ANGIOGRAPHY (CAG). SINCE EPI ABLATION WAS PERFORMED, THE PHYSICIAN CHECKED FOR ANY EFFECTS DUE TO THE ABLATION WITH THE CORONARY ANGIOGRAM, HOWEVER, NO ABNORMALITIES WERE FOUND. PATIENT FULLY RECOVERED. IT WAS REPORTED THAT PROCEDURAL ACTIVATED CLOTTING TIME (ACT) 128 SECONDS THEN 163 SECONDS THEN 163 SECONDS THEN 125 SECONDS AND THEN 98 SECONDS. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO EVIDENCE OF STEAM POP. THE FLOW SETTING WAS 10 ML BECAUSE OF EPI CASE. THERE WERE NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 22148586 ↗
• MalfunctionMar 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR RMT THERMOCOOL AND THE COATING AT THE TIP OF THE CATHETER WAS LIFTING. AT THE TIME OF FLUSHING, THE COATING AT THE TIP OF THE CATHETER WAS LIFTING. RESOLVED BY REPLACING THE NAVISTAR RMT THERMOCOOL CATHETER TO ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 26-FEB-2025. THE EVENT OCCURRED PRE-OP. ADDITIONAL INFORMATION WAS RECEIVED ON 27-FEB-2025. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE CATHETER WAS NOT INSERTED INTO THE PATIENT'S BODY. THE CATHETER WAS NOT PRE-SHAPED. NO SHEATH WAS INVOLVED IN THE ALLEGED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21578552 ↗
• MalfunctionOct 8, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT)ABLATION PROCEDURE WITH A NAVISTAR RMT THERMOCOOL AND THE CATHETER WAS NOT FLUSHING PROPERLY DURING THE PROCEDURE. THERE WERE NO ERROR CODES. THEY REPLACED THE TUBING WITHOUT RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED, AND THE PROCEDURE WAS CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20393284 ↗
• MalfunctionSep 10, 2024Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDVT (IDIOPATHIC DEEP VEIN THROMBOSIS) ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND THERE WAS AN IRRIGATION ISSUE. THE CARTO 3 SYSTEM WAS DISPLAYING A HIGH TEMPERATURE READINGS DURING ABLATION. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REMOVED FROM THE BODY AND THEY NOTICED THAT PARTS OF THE TIP OF THE CATHETER WAS NOT IRRIGATING PROPERLY. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182555 ↗
• InjuryJul 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A NAVISTAR RMT THERMOCOOL AND DURING THE ABLATION PHASE, THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS. A PERICARDIAL EFFUSION AND CARDIAC PERFORATION WERE NOTICED. THEY WERE DOING THEIR LAST LESION ON THE PREMATURE VENTRICULAR CONTRACTIONS (PVC) WHEN A STEAM POP WAS HEARD, AND THERE WAS A RISE IN IMPEDANCE VALUES. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS SENT TO THE INTENSIVE CARE UNIT (ICU). THE ABLATION CATHETER WAS CUT IN HALF AND DISCARDED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THAT THERE WAS NO PRODUCT MALFUNCTION. NO TRANSSEPTAL PUNCTURE WAS PERFORMED AS THIS WAS A RIGHT SIDED PROCEDURE. ABLATION WAS PERFORMED PRIOR TO NOTING THE EFFUSION. GENERATOR PARAMETERS WERE POWER CONTROLLED MODE AT 50 W. TEMPER CUTOFF AT 45 C. THE TEMP WAS AROUND 36-41C, THE POWER WAS 50W AND THE IMPEDANCE STARTED AT 115 OHMS AND DROPPED TO ABOUT 95 OHMS OVER 38S. THE IMPEDANCE WAS NOT EVEN CLOSE TO REACHING CUTOFF.

  Patient problems: Cardiac Perforation

  MAUDE report 19839322 ↗
• MalfunctionMay 2, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE WITH TWO NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER¿S AND IRRIGATION ISSUES DURING USE ON THE PATIENT OCCURRED. THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER WAS ONLY FLUSHING OUT OF 4 OF ITS 6 IRRIGATION PORTS. IT WAS DISCOVERED AFTER ATTEMPTING RADIO FREQUENCY (RF) DELIVERY AND A PUMP ERROR APPEARED (CODE UNKNOWN) AFTER 10 SECONDS OF ABLATION. THE CATHETER WAS REMOVED AND THE IRRIGATION ISSUE WAS NOTICED. IT WAS CONFIRMED IT WAS IRRIGATING DURING RF DELIVERY. THE CATHETER WAS EXCHANGED (WITH ONE FROM THE SAME LOT) AND THE SAME ISSUE OCCURRED. THEY REPLACED THE CATHETER AGAIN. THIS TIME FROM A DIFFERENT LOT AND THERE WERE NO ISSUES. THE PROCEDURE CONTINUED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETERS. THE SMARTABLATE PUMP WAS USED. THE STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS SWAPPING CATHETER, THEN SWAPPING PUMP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230967 ↗
• MalfunctionMay 2, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE WITH TWO NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER¿S AND IRRIGATION ISSUES DURING USE ON THE PATIENT OCCURRED. THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER WAS ONLY FLUSHING OUT OF 4 OF ITS 6 IRRIGATION PORTS. IT WAS DISCOVERED AFTER ATTEMPTING RADIO FREQUENCY (RF) DELIVERY AND A PUMP ERROR APPEARED (CODE UNKNOWN) AFTER 10 SECONDS OF ABLATION. THE CATHETER WAS REMOVED AND THE IRRIGATION ISSUE WAS NOTICED. IT WAS CONFIRMED IT WAS IRRIGATING DURING RF DELIVERY. THE CATHETER WAS EXCHANGED (WITH ONE FROM THE SAME LOT) AND THE SAME ISSUE OCCURRED. THEY REPLACED THE CATHETER AGAIN. THIS TIME FROM A DIFFERENT LOT AND THERE WERE NO ISSUES. THE PROCEDURE CONTINUED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETERS. THE SMARTABLATE PUMP WAS USED. THE STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS SWAPPING CATHETER, THEN SWAPPING PUMP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19230966 ↗
• MalfunctionMar 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER. WHEN USING THE DEVICE IN THE PATIENT BY RIGHT ROUTE, THERE WERE NO ISSUES. HOWEVER, WHEN THE MEDICAL TEAM TRIED TO GO TO LEFT ARTERIAL ROUTE, THE ANATOMICAL DIFFICULTIES OF THE PATIENT PRESENTED AN ISSUE. THE PHYSICIAN OBSERVED THE DAMAGE AFTER THE CATHETER WAS INSERTED, WHEN HE FELT THAT THE CATHETER WAS NOT RESPONDING AS USUAL DURING THE MANIPULATION (IT WAS AN AORTIC FEMORAL ACCESS, THE RESISTANCE WAS DUE TO THE UNUSUAL ANATOMY OF THE DESCENDING AORTA THAT REQUIRED A LOT OF MANIPULATION OF THE CATHETER TO GO THROUGH). THE PHYSICIAN REMOVED THE PROBE FROM THE PATIENT AND DISCOVERED THAT THE DEVICE WAS BROKEN. THE SHEATH WAS BROKEN, AND THERE WAS AN UNUSUAL ANGLE ON THE CATHETER'S SHAFT. THERE WERE NO EXPOSED WIRES OR BROKEN/LIFTED RINGS. THE DEVICE WAS REPLACED WITH ANOTHER. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18973169 ↗
• InjuryMar 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SCHLÖGL S, SCHLÖGL KS, BENGEL P, HAARMANN H, BERGAU L, RASENACK E, HASENFUSS G, ZABEL M. CONTACT FORCE SENSING MANUAL CATHETER VERSUS REMOTE MAGNETIC NAVIGATION ABLATION OF ATRIAL FIBRILLATION: A SINGLE-CENTER COMPARISON. HEART VESSELS. 2024 JAN 8. DOI: 10.1007/S00380-023-02344-8. EPUB AHEAD OF PRINT. PMID: 38189924. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: DATA COMPARING REMOTE MAGNETIC CATHETER NAVIGATION (RMN) WITH MANUAL CATHETER NAVIGATION IN COMBINATION WITH CONTACT FORCE SENSING (MCN-CF) ABLATION OF ATRIAL FIBRILLATION (AF) IS LACKING. THE PRIMARY AIM OF THE PRESENT RETROSPECTIVE COMPARATIVE STUDY WAS TO COMPARE THE OUTCOME OF RMN VERSUS (VS.) MCN-CF ABLATION OF AF WITH REGARDS TO AF RECURRENCE. SECONDARY AIM WAS TO ANALYZE PERIPROCEDURAL RISK, ABLATION CHARACTERISTICS AND REPEAT PROCEDURES. METHODS: RETROSPECTIVELY ANALYZED 452 PATIENTS UNDERGOING A TOTAL OF 605 ABLATIONS OF AF: 180 PATIENTS WERE ABLATED USING RMN, 272 USING MCN-CF. RESULTS: EXCEPT BODY MASS INDEX THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS AT BASELINE. AFTER A MEAN 1.6 ± 1.6 YEARS OF FOLLOW-UP AND 1.3 ± 0.4

  Patient problems: Pericardial Effusion

  MAUDE report 18938438 ↗
• MalfunctionFeb 1, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND THE IRRIGATION ISSUE ON THE DEVICE OCCURRED DURING USE ON THE PATIENT. INITIALLY IT WAS REPORTED THAT THE IRRIGATION HOLES SEEM TO BE BLOCKED. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 11-JAN-2024. THE ISSUE WAS NOTED DURING THE DEVICE BEING USED ON THE PATIENT. IT WAS UNKNOWN IF THERE WAS AN ERROR NOTED FROM THE IRRIGATION PUMP. IT WAS UNKNOWN IF THE PUMP WAS SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING THE ABLATION. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. REPLACING THE CATHETER RESOLVED THE ISSUE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE THAT THE IRRIGATION ISSUE ON THE DEVICE OCCURRED DURING USE ON THE PATIENT ON (B)(6) 2024 AND HAVE REASSESSED THE EVENT AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627501 ↗
• MalfunctionDec 19, 2023Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND AN IRRIGATION ISSUE OCCURRED. ABLATION STOPPED DUE TO HIGH TEMPERATURE. THEY NOTICED THAT THE IRRIGATION WAS NOT PROPER. CATHETER GOT PULLED OUT OF THE PATIENT¿S BODY TO FLUSH IT. HOLES WHERE BLOCKED. PROPER FLUSH WAS NOT POSSIBLE. THEY DETACHED THE CATHETER FROM THE IRRIGATION TUBE. IRRIGATION TUBE WAS WORKING. THEY ATTACHED IT BACK TO THE CATHETER. IRRIGATION WAS BLOCKED AGAIN. THEY USED A NEW ABLATION CATHETER. SURGERY WAS DELAYED 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. TEMPERATURE TOO HIGH ERROR DISPLAYED ON THE SMARTABLATE. THE CATHETER GOT PULLED OUT OF THE PATIENT¿S BODY TO FLUSH PROPERLY. CATHETER WAS ONLY DRIPPING. THEY THEN DETACHED THE IRRIGATION TUBE TO TEST IF THE ISSUE WAS THERE. IRRIGATION TUBE WAS WORKING PERFECTLY. THEY ATTACHED THE CATHETER AGAIN, BUT COULD NOT PROPERLY FLUSH THE CATHETER. IT WAS STILL ONLY DRIPPING. THEREFORE, THEY OPENED A NEW CATHETER. THE ISSUE WAS RESOLVED. SETTINGS WERE CORRECT AND WERE NOT CHANGED WITHIN THE PROC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357562 ↗
• MalfunctionDec 11, 2023Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER WHEREIN IRRIGATION OF CATHETER WAS NOT POSSIBLE. IT WAS REPORTED THAT ABLATION STOPPED WORKING, TEMPERATURE PEAKED AND IRRIGATION OF CATHETER WAS NOT POSSIBLE ANYMORE. THE CATHETER GOT PULLED OUT OF PATIENT TO TRY A FULL FLUSH OF THE CATHETER AND THE HOLES WERE BLOCKED. THEY USED A NEW CATHETER AND SUCCESSFULLY COMPLETED THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307398 ↗
• InjuryNov 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE ABLATION PROCEDURE WHICH INCLUDED THE USE OF A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PER PERICARDIOCENTESIS, A STERNOTOMY AND PROLONGED HOSPITALIZATION. AFTER ABLATION, THEY WERE PREPARING TO GO LEFT SIDED AND PATIENT BECAME HYPOTENSIVE. USING ULTRASOUND THEY SAW A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. THEN A STERNOTOMY WAS PERFORMED PATIENT WAS STABLE WHEN THEY LEFT THE LAB TO GO TO THE INTENSIVE CARE UNIT (ICU) AND HOSPITALIZED FOR A WEEK. DISCHARGED WITH FULL RECOVERY. PHYSICIAN'S OPINION THE CAUSE WAS ABLATING ON THE FREE WALL OF THE RIGHT VENTRICLE WHERE TISSUE IS THINNER. NO STEAM POP. CORRECT SETTINGS ON DEVICES AND NO ERROR MESSAGES ON THE EQUIPMENT.

  Patient problems: Cardiac Tamponade

  MAUDE report 18187589 ↗
• InjuryNov 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE USING A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER. DURING THE ABLATION PHASE, THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIAL DRAINAGE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. TRANSSEPTAL PUNCTURE WAS PERFORMED. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF STEAM POP. THE PROCEDURE WAS NOT COMPLETED.

  Patient problems: Cardiac Tamponade

  MAUDE report 18076486 ↗
• InjuryOct 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER. DURING RF (RADIOFREQUENCY) DELIVERY, THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. THERE WAS DIFFICULT VENOUS ENTRY WITH THE INTRODUCER SHEATHS AS THE PATIENT HAD TORTUOUS ANATOMY, AND THAT THE VIZIGO HAD TO BE PUT THROUGH A LARGER, 14 FR. SHEATH FOR ACCESS. THE PHYSICIAN ALSO HAD DIFFICULTY MANIPULATING THE PENTARAY WITHIN THE VIZIGO SHEATH WHICH WAS TRANSSEPTAL IN THE LEFT ATRIUM (LA). THE PENTARAY WAS REMOVED AND EXCHANGED WITH AN RMT/STEREOTAXIS CATHETER TO COMPLETE MAPPING AND BEGIN ABLATING IN THE LA (MANUAL CATHETER MANIPULATION WAS SWITCHED TO ROBOTIC, THE CASE WAS CONTINUED USING THE STEREOTAXIS SYSTEM). DURING RF DELIVERY IT WAS NOTICED ON INTRACARDIAC ECHO THAT THE PATIENT HAD AN "EVOLVING EFFUSION." THE PATIENT WAS HEMODYNAMICALLY STABLE SO ABLATION WAS CONTINUED UNTIL THE PULMONARY VEINS WERE ELECTRICALLY ISOLATED. THE EFFUSION WAS GETTING LARGER SO THE PROCEDURE WAS STOPPED AND INTERVENTIONAL CARDIOLOGY WAS BROUGHT IN. A PERICARDIOCENTESIS WAS ALSO PERFORMED. AFTERWARD, THE PATIENT WAS IN STABL

  Patient problems: Cardiac Tamponade

  MAUDE report 17986928 ↗
• DeathJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, CARDIAC ARREST AND ULTIMATELY PASSED AWAY. IT WAS REPORTED WHILE ABLATING IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), THEY NOTICED THAT THE PATIENT'S BLOOD PRESSURE DROPPED. THE STAFF BEGAN COMPRESSIONS ON THE PATIENT. THE PHYSICIAN UTILIZED THE INTRACARDIAC ECHO AND CONFIRMED THE PATIENT HAD A LARGE PERICARDIAL EFFUSION IN EPICARDIAL SPACE. UNABLE TO CONTROL BLOOD LOSS, AND UNABLE TO STABILIZE PATIENT FOR SURGERY. THE PHYSICIAN CALLED FOR A CODE AND BEGAN A PERICARDIOCENTESIS PROCEDURE. THE CALLER IS UNAWARE OF THE AMOUNT OF FLUID THAT WAS REMOVED FROM THE PERICARDIAL SPACE. THE CODE CONTINUED AND COMPRESSIONS WERE CONTINUED FOR ANOTHER HOUR AND A HALF. THE PHYSICIAN THEN TERMINATED THE CODE AND PRONOUNCED THE DEATH OF THE PATIENT. PHYSICIAN DID NOT BELIEVE IT DUE TO PRODUCT MALFUNCTION BUT CAUSE IS UNDETERMINED AT THIS TIME. THE BWI REPRESENTATIVE NOTED THAT NO IMPEDANCE SPIKE WAS NOTICED DURING THE ABLATION PHASE OF THE PROCEDURE. TRANSSEP

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 17362074 ↗
• MalfunctionJun 7, 2023Break; Insufficient Cooling; Break; Insufficient Cooling

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND A BROKEN TIP ISSUE OCCURRED. AFTER THE PROCEDURE, IT WAS NOTICED THAT THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER TIP WAS BROKEN AND SEEMED TO BE FOLDED OR SQUEEZED SOMEWHERE. THE PROCEDURE COULD BE FINISHED NORMALLY, BUT THE CATHETER TEMPERATURE ROSE DURING ABLATION VERY QUICKLY TO 50 DEGREES CELSIUS AND THE SMARTABLATE GENERATOR HAD A "CATHETER TEMPERATURE TOO HIGH" MESSAGE SEVERAL TIMES. THE PROCEDURE WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. A PICTURE WAS PROVIDED. THE DAMAGE RESULTED IN WIRES/AND OR BRAID BEING EXPOSED. THERE WAS NO PATIENT CONSEQUENCE. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. NO DIFFICULTY IN INSERTING. BIT OF RESISTANCE DURING REMOVAL. NO DETACHMENT. SURFACE OF SHAFT WAS BROKEN AND SOME BRAIDING/WIRES WERE EXPOSED. ABBOTT SWARTZ SHEATH SL0 OR SL1 8.5F AND ABBOTT AGILIS SHEATH 8.5F USED. THE CUT OFF WAS NOT EXCEEDED. MAX TEMPERATURE RECORDED WAS 50. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078770 ↗
• MalfunctionApr 27, 2023Break; Manufacturing, Packaging or Shipping Problem; Break; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) CARDIAC ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND A BROKEN TIP ISSUE OCCURRED. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THAT THE SPLINE OF THE CATHETER IS PHYSICALLY DAMAGED. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE STATED THAT BEFORE INSERTING THE CATHETER INTO THE BODY, IT WAS NOTICED THAT THERE IS A CRACK IN THE SPLINE BEFORE THE ELECTRODES. THE BWI REPRESENTATIVE REPORTED THAT THE SPLINE IS VERY "FLIMSY." THE CATHETER DAMAGE WAS ISOLATED TO THE INTERIOR SHAFT IMMEDIATELY PROXIMAL TO THE ELECTRODES. NO WIRES OR SHARP COMPONENTS WERE EXPOSED. THE PHYSICIAN NOTICED THE DEFECT IMMEDIATELY UPON OPENING THE PRODUCT. IT WAS NOT INSERTED THROUGH A SHEATH, MANIPULATED, NOR INTRODUCED TO THE PATIENT¿S BODY. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED AND THE PROCEDURE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THIS EVENT WAS ASSESSED AS AN OUT-OF-BOX FAILURE, BROKEN TIP ISSUE AND IS MDR REPORTABLE TO THE US FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828372 ↗
• DeathFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE THAT INCLUDED USE OF NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND EXPERIENCED CARDIAC PERFORATION, TAMPONADE, ASYSTOLE REQUIRING PERICARDIOCENTESIS AND THE PATIENT SUBSEQUENTLY DIED. IT WAS REPORTED THAT DURING AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) CASE, A CARDIAC PERFORATION WAS NOTICED IN THE PATIENT. THE CALLER REPORTED THAT IT WAS NOTICED ON THE RECORDING SYSTEM THAT THE PATIENT WENT ASYSTOLIC FOR ABOUT 5 SECONDS. THE CALLER REPORTED THAT THEY THEN PACED WITH THE PATIENT, AND THE PATIENT WAS RESTORED TO NORMAL HEART RHYTHM. THE CALLER REPORTED THAT THE PHYSICIAN THEN RE-INSERTED THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER INTO THE BODY, AND IT WAS CONFIRMED ON ICE THAT THERE WAS A CARDIAC PERFORATION IN THE PATIENT. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS, AND ABOUT 2200 CC OF FLUID WAS REMOVED. THE CALLER REPORTED THAT THE PATIENT WAS THEN ADMITTED TO THE OPERATING ROOM (OR) FOR SURGICAL REPAIR. THE CALLER REPORTED THAT THE PATIENT IS IN STABLE CONDITION IN THE OR. THE CALLER CALLED BACK AT A LATER TIME AND REPORTED THE PATIENT HAD PASSED AWAY ON

  Patient problems: Asystole; Cardiac Perforation; Cardiac Tamponade

  MAUDE report 16359086 ↗
• InjuryDec 19, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 63-YEAR-OLD MALE PATIENT UNDERWENT AN AFIB ¿ PAROXYSMAL ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC TAMPONADE (CT) REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT THE PATIENT SUFFERED A CARDIAC PERFORATION. AT THE END OF THE CASE, ABLATION HAS BEEN COMPLETED, THE SOUNDSTAR CATHETER WAS USED TO CHECK THE HEART, AND A PERICARDIAL EFFUSION (PE) WAS NOTED. THE EFFUSION WAS DISCOVERED/NOTICED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING. THERE WAS NO EVIDENCE OF ANY EFFUSION PRESENT BEFORE THE PROCEDURE. AFTER OBSERVING THE EFFUSION FOR A LITTLE WHILE, THE PATIENT'S BLOOD PRESSURE DROPPED, AND THE PHYSICIAN DECIDED TO PERFORM A PERICARDIOCENTESIS. THEY DO NOT KNOW HOW MUCH FLUID HAS BEEN REMOVED AT THIS TIME. PATIENT WAS HEMODYNAMICALLY STABLE AT THE TIME OF THE CALL AND IN SINUS RHYTHM. THE ADVERSE EVENT WAS DISCOVERED POST ABLATION. NO OPINION SHARED BY THE PHYSICIAN ON THE CAUSE OF THE ADVERSE EVENT. THE BWI REPRESENTATIVE STATED THAT IT WAS A PERFORATION (BWI REPRESENTATIVE¿S OPINION). THE OUTCOME OF THE ADVERSE EVENT WAS UNKNOWN. BAYLIS STANDARD C

  Patient problems: Cardiac Tamponade

  MAUDE report 16011499 ↗
• MalfunctionDec 19, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND A DEFLECTION STUCK ISSUE OCCURRED. THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER TIP WAS VERY FLIMSY AND WAS NOT RESPONDING CORRECTLY ABOUT MID-CASE. THE PHYSICIAN HAD TO REMOVE THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND THEY HAD TO DISENGAGE THE MAGNETIC TO REMOVE THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AS IT WAS ACTING LIKE IT WAS STUCK. THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER WAS EXCHANGED AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. MAGNETS WERE NOT ENGAGED. THERE WAS DIFFICULTY IN REMOVING THE CATHETER. THERE WAS NO RING, ELECTRODE OR OTHER PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A DEFLECTION STUCK ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006954 ↗
• MalfunctionNov 11, 2022Device Contamination with Body Fluid; Contamination /Decontamination Problem; Device Contamination with Body Fluid; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER AND A FOREIGN MATERIAL WAS FOUND ON THE CATHETER. IT WAS REPORTED THAT ON THE PROXIMAL END OF THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER TIP, ONE OF THE NURSES FOUND A DARK COLORED SUBSTANCE AFTER RETRACTING THE CATHETER OUT OF THE PATIENT. UNFORTUNATELY, THAT SUBSTANCE HAD BEEN THROWN AWAY, BUT THE REMAINS OF IT CAN STILL BE SEEN ON THE NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER. IT SURROUNDED THE TIP (RING-SHAPE) AND SUPPOSEDLY WAS EITHER CLOTTED BLOOD OR REMNANTS FROM THE AGILIS STEERABLE SHEATH IT WENT THROUGH. THE EVENT OCCURRED INTRA-OP. THERE WERE NO PATIENT CONSEQUENCES. NO ACTION WAS TAKEN TO RESOLVE THE ISSUE AS IT WAS FOUND OUT AFTER THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED A ST. JUDE ABBOTT, AGILIS STEERABLE SHEATH, 8.5FR INNER DIAMETER WAS USED DURING THIS CASE. THE PHYSICIAN DID NOT FEEL ANY RESISTANCE WHILE INTRODUCING OR RETRACTING THE CATHETER FROM THE SHEATH. THE FOREIGN MATERIAL WAS RED/BLACK COLORED, FELT HARD, SHAPED AROUND THE PROXIMAL RING OF THE TIP. THE ISSUE WAS ENCOUNT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777850 ↗