NaviStar NS7TCDL174HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10846835000597), received between Feb 27, 2017 and Feb 19, 2026 — classified as 1 death, 34 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (30 reports).

1 other recall cover devices cleared under the same FDA submission (P990025); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A NAVISTAR. THE PATIENT EXPERIENCED AN AV BLOCK INITIALLY TREATED WITH TEMPORARY PACEMAKER. THE OUTCOME OF THE ADVERSE EVENT WAS UNCHANGED. CONDUCTION RECOVERED TO A 2:1 ATRIOVENTRICULAR BLOCK BUT DID NOT NORMALIZE; A PACEMAKER WAS SUBSEQUENTLY IMPLANTED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF PACEMAKER IMPLANTATION. AV BLOCK OCCURRED. WHILE WAITING AFTER THE ABLATION WAS COMPLETED, SINCE THE PATIENT REMAINED IN AV BLOCK, TEMPORARY PACEMAKER WAS INSERTED AND THE PATIENT LEFT THE ROOM. NO EXTENDED HOSPITALIZATION. THE METHOD OF CF MONITORING WAS VISITAG. THE COLORING SETTINGS FOR VISITAG WAS TOTAL TIME. NO ABNORMALITIES WERE OBSERVED PRIOR/DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 11-FEB-2026. THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PROCEDURE. AT THE ONSET OF JUNCTIONAL RHYTHM, DID NOT NOTICE IT DISPLAYED ON THE RECORDING SYSTEM. THE OUTCOME OF THE ADVERSE EVENT WAS UNCHANGED. CONDUCTION RECOVERED TO A 2:1 ATRIOVENTRICULAR BLOCK BUT DID NOT NORMALIZE; A PACEMAKER WAS SUBSEQUENTLY

  Patient problems: Heart Block

  MAUDE report 24398002 ↗
• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING CARDIAC ABLATION PROCEDURE WITH NAVISTAR CATHETER, THE PATIENT EXPERIENCED CORONARY VASOSPASM TREATED WITH PERCUTANEOUS BALLOON INFLATION AND INTRA-AORTIC BALLOON PUMP (IABP) PLACED, WHICH REQUIRED PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT DURING AORTIC CORONARY CUSP ABLATION WITH NAVISTAR CATHETER, CONTRAST EXAMINATION WAS PERFORMED BECAUSE THE PATIENT COMPLAINED OF CHEST PAIN. CORONARY VASOSPASM WAS OBSERVED IN A SEGMENT OF THE LEFT CORONARY ARTERY, AND PERCUTANEOUS BALLOON INFLATION WAS PERFORMED. THE ABLATION WAS STOPPED AT THAT POINT. AFTER THE PROCEDURE, THE PATIENT'S SYMPTOMS WERE IMPROVING; HOWEVER, AN IABP WAS PLACED, AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN¿S ASSESSMENT OF THE HEALTH HAZARD WAS NON-SERIOUS (MODERATE/MINOR). EXTENDED HOSPITALIZATION WAS NOTED. THE COLORING SETTINGS FOR VISITAG WAS TAG INDEX. THE VISITAG ADDITIONAL FILTERS USED WAS IMPEDANCE DROP. THE RELATIONSHIP WITH THE PRODUCT WAS CAUSAL. 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.

  Patient problems: Vasospasm

  MAUDE report 23824323 ↗
• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE REPORT INDICATED THAT DURING AN ABLATION PROCEDURE WITH A NAVISTAR CATHETER, THE PATIENT EXPERIENCED HEART BLOCK TREATED WITH A PERMANENT PACEMAKER. IT WAS REPORTED THAT THE PATIENT HAD A COMPLETE HEART BLOCK. DURING ABLATION, AND REALLY FAR FROM THE HIS, TWO DROPPED/NON-CONDUCTING ATRIAL BEATS WERE NOTICED. THE PHYSICIAN CAME OFF ABLATION AND VENTRICULAR PACED THE PATIENT FOR CONDUCTION. THE PROCEDURE WAS ABORTED. THE INJURY WAS CONFIRMED BY VISUALIZING THE SIGNALS DISPLAYED ON THE CARTO 3 SYSTEM. A PERMANENT PACEMAKER WAS PLACED IN THE PATIENT. THE LAST KNOWN PATIENT STATUS WAS REPORTED AS STABLE. GENERATOR USED FOR ABLATION WAS A NGEN. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS ANATOMY RELATED. THE PATIENT REQUIRED OVERNIGHT HOSPITALIZATION.

  Patient problems: Heart Block

  MAUDE report 22524623 ↗
• InjuryJul 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH NAVISTAR CATHETER, THE PATIENT EXPERIENCED AN IMPAIRED SEPTAL MOVEMENT. AFTER THE PROCEDURE WAS COMPLETED USING THE NAVISTAR CATHETER, ¿THE MOVEMENT OF SEPTUM HAS BECOME IMPAIRED¿. THERE WAS NO EXTENDED HOSPITALIZATION REQUIRED. CAUSAL RELATIONSHIP WITH PRODUCT WAS UNKNOWN. THERE WERE NO ERROR MESSAGES OBSERVED ON HARDWARE/CAPITAL EQUIPMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED TO PROVIDE FURTHER DETAILS ABOUT THE REPORTED EVENT. HOWEVER, NO INFORMATION HAS BEEN PROVIDED.

  Patient problems: Intraoperative Cardiac Injury

  MAUDE report 22455520 ↗
• InjuryJul 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT (ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA) ABLATION WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED HEMOPERICARDIUM THAT REQUIRED PERICARDIOCENTESIS. A PATIENT WHO HAD A RADIOFREQUENCY ABLATION WAS DIAGNOSED WITH HEMOPERICARDIUM BY ECHOCARDIOGRAPHY ABOUT 20 MINUTES AFTER THE PROCEDURE. AFTER THAT, A PUNCTURE OF THE PERICARDIUM WAS PERFORMED AND 120 ML OF VENOUS BLOOD WAS EVACUATED. THE NEXT DAY DRAINAGE WAS REMOVED FROM THE PERICARDIUM CAVITY. THE PATIENT FELT WELL. PATIENT FULLY RECOVERED HOWEVER REQUIRED 2 DAYS OF EXTENDED HOSPITALIZATION. DURING ABLATION, NOTHING UNUSUAL HAPPENED, EVERYTHING WAS REPORTED TO BE STANDARD. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PATIENT'S CONDITION / PROCEDURE. NO EVIDENCE OF STEAM POP WAS NOTED.

  Patient problems: Cardiac Tamponade

  MAUDE report 22375614 ↗
• InjuryMar 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NAVISTAR AND THE PATIENT EXPERIENCED 1ST DEGREE HEART BLOCK / MYOCARDIAL EDEMA THAT REQUIRED MEDICATION. PATIENT LEFT 4 HOURS AFTER PROCEDURE AGAINST MEDICAL ADVICE. THE PATIENT CAME BACK A FEW DAYS LATER WITH PALPITATIONS. THE PATIENT WAS NOTICED TO HAVE TACHYCARDIA AND PROLONGED HV TIME (HIS BUNDLE TO THE VENTRICLE). PATIENT HAD A AV BLOCK 1ST DEGREE. THE PATIENT DID NOT HAVE THESE SYMPTOMS PRIOR TO LEAVING THE HOSPITAL POST PROCEDURE. THE INTERVENTION PROVIDED WAS SYSTEMICALLY GLUCOCORTICOIDS DUE TO MYOCARDIAL EDEMA (PRESUMABLY) OVER 3 DAYS. PATIENT FULLY RECOVERED. UNDER THIS TREATMENT THE AV BLOCK DISAPPEARED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS PATIENT CONDITION. THE SUSPECTED CAUSE OF THE MYOCARDIAL EDEMA WAS DUE TO RF-ABLATION OF THE SLOW PATHWAY; MAYBE A SIDE EFFECT BECAUSE OF THE NEAR DISTANCE. THE ADVERSE EVENT DIAGNOSIS WAS TRANSIENT AV BLOCK 1ST DEGREE.

  Patient problems: Heart Block; Tachycardia; Unspecified Tissue Injury

  MAUDE report 21505881 ↗
• MalfunctionJan 9, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE CATHETER WAS NOT RETRACTING BACK AND REMAINED IN A FIXED POSITION. PHYSICIAN NOTICED THAT THE DEVICE WAS NOT 'BEHAVING CORRECTLY', AND PULLED CATHETER OUT OF PATIENT AND NOTICED IT WAS NOT RETURNING TO NORMAL UNDEFLECTED POSITION. THERE WERE NO ISSUES WITH REMOVING THE CATHETER. THE PUSH PULL WAS WORKING, AND IT SEEMED THAT THE RESPONSE WAS NOT 1/1 WITH THE TIP OF THE CATHETER. IT WAS STUCK IN PARTIAL DEFLECTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21115198 ↗
• MalfunctionDec 19, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT)/WOLFF-PARKINSON-WHITE (WPW) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE MEDICAL TEAM NOTED STICKY FILM OVER THE TOP OF THE CATHETER. THE STICKY MATERIAL WAS HARD TO PEEL OFF THE TIP OF THE CATHETER AND NOT NOTICEABLE TO THE NAKED EYE UNTIL THE SURGICAL FELLOW SAID THAT THE CATHETER WAS TIGHT GOING INTO THE SHEATH. THE DEVICE WAS USED INSIDE THE PATIENT TO MAP. HOWEVER, THE DEVICE WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20982597 ↗
• InjuryAug 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED TRANSIENT AV BLOCK. FIRST, IT WAS REPORTED THAT NOISE OCCURRED ON THE 1-2 ELECTRODES OF THE THERMOCOOL SMARTTOUCH CATHETER (INTRACARDIAC ONLY, IN BOTH CARTO 3 AND LAB) IMMEDIATELY AFTER INSERTION INTO THE PATIENT'S BODY. CABLE WAS REPLACED BUT THE ISSUE CONTINUED, AND THIS ISSUE WAS IMPROVED BY REPLACING THE CATHETER TO ANOTHER NEW ONE. AFTER THAT, THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THEN IT WAS REPORTED THAT THE PATIENT HAD TRANSIENT HEART BLOCK. THE PHYSICIAN THOUGHT THE ADVERSE EVENT WAS CAUSED BY THE ABLATION PERFORMED WITH THE NAVISTAR CATHETER VERY CLOSE TO THE HIS BUNDLE. THE EVENT WAS NOT RELATED TO THE NOISE ON THE STSF. PATIENT WAS MONITORED, NO MEDICATION WAS PERFORMED DURING THE PROCEDURE. WHEN THE PATIENT LEFT FROM THE CATHETER ROOM, IT WAS CONFIRMED THAT THE FIRST DEGREE ATRIOVENTRICULAR BLOCK WAS PERSISTED.

  Patient problems: Heart Block

  MAUDE report 20010008 ↗
• MalfunctionAug 9, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA/WOLFF-PARKINSON-WHITE (AVRT/WPW) ABLATION PROCEDURE WITH A NAVISTAR AND WHEN REMOVING THE ABLATION CATHETER FROM THE BODY, THE TIP OF THE CATHETER PARTIALLY SEPARATED, EXPOSING INTERNAL WIRES. THE ISSUE OCCURRED AT THE END OF THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS NOTED THAT THE DAMAGE RESULTED IN LIFTED RINGS. THERE WAS DIFFICULTY DURING THE REMOVAL OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19954331 ↗
• InjuryMay 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT (ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA) ABLATION WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED AV (ATRIOVENTRICULAR) BLOCK THAT REQUIRED TEMPORARY PACEMAKER. AV CONDUCTION DID NOT RECOVER INTRA PROCEDURE. TEMPORARY PACEMAKER WAS IMPLANTED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS PROCEDURE AND PATIENT CONDITION. ADVERSE EVENT OCCURRED DURING SLOW POSTERIOR WALL (PW) ABLATION. OUTCOME SO FAR WAS UNCHANGED, AND THE PHYSICIAN SUGGESTED TO WAIT A FEW DAYS AS AV CONDUCTION MIGHT RECOVER. PATIENT REQUIRED OVERNIGHT HOSPITALIZATION FOR MONITORING.

  Patient problems: Heart Block

  MAUDE report 19280896 ↗
• MalfunctionMar 25, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A BROKEN PEEK HOUSING WITH INTERNAL COMPONENTS EXPOSED. DURING THE PROCEDURE, THERE WAS SIGNAL INTERFERENCE NOISE WAS OBSERVED ON THE INTRACARDIAC CHANNEL. DURING THE SIGNAL INTERFERENCE, THERE CATHETER WAS INSIDE OF THE PATIENT'S BODY. THE MEDICAL TEAM STILL HAD ACCESS TO ECG (ELECTROCARDIOGRAM) CHANNELS. 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 18970285 ↗
• MalfunctionMar 19, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WHICH INCLUDED A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND WHEN THE NURSE TOOK THE CATHETER OUT OF THE BOX, THE PACKAGING WAS ALREADY OPEN AND CLEARLY NOT STERILE ANYMORE. THE PACKAGING IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937298 ↗
• InjuryFeb 21, 2024Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Patient Device Interaction Problem; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) CARDIAC ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED A COMPLETE HEART BLOCK THAT REQUIRED INTERVENTION. IN ADDITION, A THROMBUS/CLOT WAS NOTED ON THE TIP OF THE CATHETER. STEAM-POP OCCURRED DURING THE PROCEDURE, SLOW PATHWAY ABLATION. THE STEAM-POP- OCCURRED DURING SECOND RADIO FREQUENCY (RF) APPLICATION, TARGET POWER AND TEMPERATURE WERE 30W AND 55C. DURING THE ABLATION, THE POWER WAS TITRATED AND DELIVERED BETWEEN 20 TO 30 WATTS ONLY. SUDDENLY THE PHYSICIAN FELT AND HEARD A POP AND STOPPED THE ABLATION. THE IMPEDANCE AND TEMPERATURE RAISED AT THAT SAME MOMENT. THE PATIENT HAD A COMPLETE AV CONDUCTION BLOCK AND NEEDED IMMEDIATELY TO BE STIMULATED WITH A CATHETER INTO THE VENTRICLE. THIS TOOK AROUND 8 SECONDS. THE AV CONDUCTION RESTORED WITHIN THE NEXT 2-3 MINUTES AND REMAINED SO UNTIL THE END OF THE PROCEDURE. TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED WITH NO IMPACT WAS NOTED BY THE PHYSICIAN. PROCEDURE SUCCESSFULLY COMPLETED. A THROMBUS/CLOT AND CHAR WERE NOTED ON THE TIP OF THE CATHETER. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIF

  Patient problems: Heart Block

  MAUDE report 18750537 ↗
• InjuryJan 29, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED MEDICAL INTERVENTION AND HOSPITALIZATION. A PERICARDIAL TAMPONADE WAS CONFIRMED IN RIGHT VENTRICLE WITH BSX WOVEN CATHETER. BIOSENSE NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER WAS IN RIGHT ATRIUM BUT WAS NOT USED FOR NAVIGATION WHEN THE TAMPONADE OCCURRED. THE PHYSICIAN SUCCESSFULLY PERFORMED AN AVNRT WITH THE BIOSENSE WEBSTER 4MM NAVISTAR CATHETER. DURING THE WAITING TIME AFTER THE ABLATION, THE PHYSICIAN REALIZED THAT THERE IS A TAMPONADE IN THE RIGHT VENTRICLE. THE PHYSICIAN REPORTED THAT HE PROBABLY PERFORATED ALREADY WHEN HE PLACED THE RV IN THE RIGHT VENTRICLE BEFORE THE 4MM NAV CATHETER WAS IN THE HEART AND THE ABLATION STARTED. THE PHYSICIAN TREATED THE TAMPONADE ON HIS OWN BY GIVING "BUTAMIN". THIS STOPPED THE BLEEDING AFTER SEVERAL MINUTES. NO THORACAL PUNCTURE WAS NECESSARY. THE PATIENT WAS KEPT ON TABLE UNTIL BLOOD PRESSURE WAS STABILIZED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR SUPERVISION FOR ONE NIGHT. THE PHYSICIAN MENTIONED ALREADY DURING THE PRO

  Patient problems: Cardiac Tamponade

  MAUDE report 18603354 ↗
• MalfunctionJan 12, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE MEDICAL TEAM DISCOVERED THAT THE HANDLE WAS DIRTY EVEN THOUGH IT HAD JUST BEEN OPENED FROM ITS PACKAGING. THE DIRTINESS WAS WHITE IN COLOR, "LIKE A HAND STAIN". ADDITONALLY, THE CARDBOARD USED TO HOLD THE NAVISTAR CATHETER IN THE STERILIZED BAG SHOWED SIGNS OF HAVING BEEN WET ONCE. THE ISSUE WAS FOUND IMMEDIATELY AFTER OPENING THE CATHETER IN THE STERILIZED BAG. THE CATHETER WAS REPLACED WITH ANOTHER DEVICE (A THERMOCOOL SMARTTOUCH) AND THE PROCEDURE WAS COMPLETED WITHOUT PROBLEMS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507560 ↗
• InjuryAug 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) CARDIAC ABLATION PROCEDURE THAT INCLUDED NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AFTER THE PROCEDURE OF PSVT WAS COMPLETED (AT LEAST 30 MINUTES AFTER THE LAST ABLATION), THE BLOOD PRESSURE DECREASED. A PERICARDIAL EFFUSION WAS CONFIRMED ON COMPUTED TOMOGRAPHY (CT) SO PERICARDIOCENTESIS WAS PERFORMED. DURING THE PROCEDURE, THE ABLATION TO SP AND LEFT KENT WAS CONDUCTED WITH NAVISTAR CATHETER. THE TRANSSEPTAL PUNCTURE WAS NOT CONDUCTED BECAUSE THE LEFT ATRIAL APPROACH WAS A TRANS-AORTIC APPROACH. ABLATION WAS PERFORMED BEFORE PERICARDIAL EFFUSION WAS DETECTED. NO STEAM POP CONFIRMED. NON-IRRIGATION CATHETER WAS USED. COLOR SETTINGS FOR VISITAG: TOTAL TIME. THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER INC. PRODUCTS.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 17559309 ↗
• InjuryJun 29, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED A HEART BLOCK AND REQUIRED PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT A SUPRA-HISIAN BLOCK OCCURRED DURING AVNRT PROCEDURE. ABLATION POINT DISTANT 17 MM FROM THE HIS CLOUD. THE PATIENT STAYED ONE DAY IN THE HOSPITAL WAITING TO RECOVER THE AV NODE. THIS ADVERSE EVENT DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. THE PROCEDURE WAS STOPPED, AND THE PATIENT WAS KEPT UNDER OBSERVATION FOR ONE NIGHT IN THE HOSPITAL TO CHECK IF THE SINUS RHYTHM WAS BACK TO NORMAL. IT WAS REPORTED THAT THE OUTCOME WAS ¿PROBABLY IMPROVED OR UNCHANGED¿.

  Patient problems: Heart Block

  MAUDE report 17228969 ↗
• DeathJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT SUFFERED BRADYCARDIA AND VENTRICULAR FIBRILLATION AND SUBSEQUENTLY DIED. A PATIENT WITH A MYOCARDIOPATHY WAS TREATED BY A MACROENTRY TACHICARDIA WITH GENERAL ANESTHESIA. ABLATION PROCEDURE WAS SUCCESSFUL IN THE RIGHT ATRIUM CIRCUIT (TEMPERATURE CONTROL MODE - 55ºC /50W). TACHYCARDIA WAS NOT INDUCIBLE AFTER ABLATION TREATMENT. ABLATION CATHETER (NAVISTAR 4MM) AND DECAPOLAR CATHETER (DECANAV) WAS REMOVED FROM THE PATIENT AND SUDDENLY, THE PATIENT SUFFERED A BRADYCARDY AND AFTER THAT, A VENTRICULAR FIBRILLATION. SEVERAL CARDIOVERSION WERE NECESSARY TO RECOVER THE NORMAL HEART PRESSURE, BUT AFTER MANY HOURS TRYING TO RECOVER THE PATIENT, SHE DIED. IN PHYSICIAN¿S OPINION, THE CAUSE OF DEATH WAS MAYBE HYPOXEMIA DURING AWAKENING OF GENERAL ANESTHESIA OR ANY THROMBOEMBOLISM FORMATION THAT COULD OCCLUDE THE SINGLE CORONARY ARTERY OF THE PATIENT.

  Patient problems: Bradycardia; Ventricular Fibrillation

  MAUDE report 17182001 ↗
• InjuryMay 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED A HEART BLOCK. IT WAS REPORTED THAT ATRIOVENTRICULAR BLOCK (AVB)OCCURRED DURING ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) TREATMENT. TIMING WAS WHEN ABLATION WAS CONDUCTED. HEART RATE HR70 WAS PRESENT AT THE JUNCTIONAL RHYTHM, AND THE PROCEDURE WAS TERMINATED WITH FOLLOW-UP. THE PHYSICIAN'S JUDGMENT ON HEALTH HAZARD OF HEART BLOCK IS NON-SERIOUS (MODERATE/MINOR). THERE WAS NO ABNORMALITY BEFORE AND DURING USE OF THE PRODUCT.

  Patient problems: Heart Block

  MAUDE report 16920503 ↗
• InjuryMar 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. CARDIAC TAMPONADE OCCURRED DURING ABLATION OF RIGHT VENTRICULAR APEX. THE PATIENT¿S BLOOD PRESSURE DECREASED. TIMING WHEN COMPLAINTS OCCURRED WAS DURING OPERATION OF THE ABLATION CATHETER. ABLATION WAS DISCONTINUED AND PERICARDIAL DRAINAGE WAS PERFORMED. AS BLOOD PRESSURE AND RESPIRATION WERE STABLE, THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE OPERATION ROOM. ATRIAL SEPTAL PUNCTURE WAS NOT PERFORMED. ABLATION WAS PERFORMED. STEAM POP WAS NOT CONFIRMED. NON-IRRIGATION CATHETER WAS USED. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THE RIGHT VENTRICULAR APEX WAS RUPTURED FROM THE ENDOCARDIAL SIDE DURING CATHETER MANIPULATION USING THE ABLATION CATHETER. NOT A PRODUCT-RELATED COMPLICATION. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO AND DURING USE OF THE PRODUCT. RELEVANT MEDICAL HISTORY WAS VT ABLATION PERFORMED TWO WEEKS BEFORE THIS ABLATION. THE PATIENT HAD NO OTHER SURGICAL HISTORY. ADDITIONAL INFORMATION WAS RE

  Patient problems: Cardiac Tamponade

  MAUDE report 16619879 ↗
• InjuryJan 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT THERE WAS A PERICARDIAL EFFUSION AFTER THE PROCEDURE. THE ABBOTT INQUIRY CORONARY SINUS CATHETER WAS PLACED IN HRA, RIGHT VENTRICULAR (RV) CATHETER IN THE RIGHT VENTRICLE. AGILIS SHEATH WAS USED IN THE PROCEDURE. NO COMPLICATIONS DURING THE PROCEDURE, PERICARDIAL EFFUSION WAS NOTICED AFTER THE CATHETERS WERE REMOVED. PERICARDIAL EFFUSION WAS PRESENT, BLOOD WAS EXTRACTED FROM THE PERICARDIUM. ADDITIONAL INFORMATION WAS RECEIVED. THE ADVERSE EVENT OCCURRED ON (B)(6) 2022. THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THIS ADVERSE EVENT, THOUGHT IT WAS DUE TO THE PROCEDURE. OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). NO TRANSSEPTAL PUNCTURE PERFORMED. ACTION WAS RECOGNIZED POST PROCEDURE, SO ABLATION WAS NOT PERFORMED PRIOR TO NOTING THE CARDIAC TAMPONADE. NO EVIDENCE OF STEAM POP.

  Patient problems: Cardiac Tamponade

  MAUDE report 16200508 ↗
• InjuryDec 29, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED HEART BLOCK AV REQUIRING TEMPORARY PACEMAKER AND PROLONGED HOSPITALIZATION. IT WAS REPORTED IN A PSVT PROCEDURE, AV BLOCK WAS DEVELOPED DURING ABLATION OF THE SLOW PATHWAY REGION. ISSUE OCCURRED WITHIN 30 MINUTES AFTER THE CATHETER USE STARTED. AFTER THE PROCEDURE, A TEMPORARY PACEMAKER WAS INSERTED, AND THE PATIENT WAS RETURNED TO THE ROOM. THE PATIENT DEVELOPED COMPLETE ATRIOVENTRICULAR BLOCK (JUNCTIONAL RHYTHM) DURING THE PROCEDURE. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THE CAUSE WAS THE PROCEDURE AND PHYSICIAN¿S OWN JUDGMENT ERROR. DURING THE ABLATION, THE PHYSICIAN PAID ATTENTION TO VARIOUS POINTS, AND THE JUDGMENT WAS DELAYED. ABLATION OF THE SLOW PATHWAY REGION WAS SUCCESSFUL BUT RESULTED IN AVB. ADDITIONAL INFORMATION RECEIVED INDICATED THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. THE OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS FULLY RECOVERE

  Patient problems: Heart Block

  MAUDE report 16065809 ↗
• InjuryNov 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN 84-YEAR-OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT SUFFERED HEART BLOCK REQUIRING TEMPORARY PACEMAKER IMPLANTATION. THE PATIENT ORIGINALLY HAD LEFT BUNDLE BRANCH BLOCK AND FIRST-DEGREE ATRIOVENTRICULAR (AV) BLOCK, SO CATHETER¿S OPERATION WAS PERFORMED CAREFULLY FOR HEART BLOCK. DURING PREMATURE VENTRICULAR CONTRACTION (PVC) MAPPING ORIGINATING FROM THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), THE CATHETER SLID, AND HEART BLOCK OCCURRED. THEREFORE, AFTER THE PROCEDURE, TEMPORARY PACEMAKER IMPLANTATION WAS PERFORMED, AND THE PATIENT LEFT THE ROOM. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THEY MAY HAVE RUBBED WHEN THE CATHETER SLIPPED. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO AND DURING THE USE OF THE PRODUCT. RELEVANT MEDICAL HISTORY INCLUDES A LEFT BUNDLE BRANCH BLOCK AND 1ST AV BLOCK. ADDITIONAL INFORMATION WAS RECEIVED INDICATING 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 PROCEDURE RELATED. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL S

  Patient problems: Heart Block

  MAUDE report 15749526 ↗
• InjuryJul 18, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN 67-YEAR-OLD FEMALE PATIENT (49 KG) UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRY TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT SUFFERED HEART BLOCK REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. DURING AN AVNRT PROCEDURE, DURING SLOW PATHWAY ABLATION, AV BLOCK OCCURRED. SPONTANEOUS PULSE WAS DEVELOPED ONLY IN THE A WAVE. HIS ELECTRICAL SIGNAL WAS NOT VISIBLE. AV BLOCK WAS OBSERVED IN SINUS IMMEDIATELY AFTER THE JUNCTION WHICH WAS NOT FAST CONTINUED. THEREFORE, ABLATION WAS IMMEDIATELY STOPPED, BUT AUTOLOGOUS PULSE DID NOT RETURN. TEMPORARY PACEMAKER IMPLANTATION WAS PERFORMED, AND THE PATIENT WAS MOVED OUT OF THE ROOM. IT WAS DECIDED TO CHECK WHETHER THE PATIENT DEVELOPED AN AUTOLOGOUS PULSE IN THE WARD. THE PATIENT WAS MONITORED UNTIL THE NEXT MORNING. THE PATIENT¿S OWN PULSE DID NOT RETURN, AND A PACEMAKER WAS IMPLANTED. THE DOCTOR COMMENTED THAT THE PATIENT¿S IMPULSE CONDUCTING SYSTEM MAY HAVE BEEN WEAK DUE TO THE PATIENT'S PRE-OPERATIVE HISTORY OF ATRIOVENTRICULAR BLOCK (TYPE 1). THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS DUE TO PATIENT CONDITION AND NOT REL

  Patient problems: Heart Block

  MAUDE report 15048051 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990025. One submission often covers many models, so check the product and lot details in each record.

• Z-0369-2010 · Oct 2, 2008 · Terminated
  Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02