EZ Steer NAVRecalls & reported problems across all models

We found 5 models of EZ Steer NAV by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 135 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2016 and May 8, 2026 — classified as 2 deaths, 98 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (44 reports).

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

Most reported EZ Steer NAV problems

EZ Steer NAV models

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

• EZ Steer NAV BN7TCDF4L

  Cardiac ablation percutaneous catheter
  2 deaths105 reports
• EZ Steer NAV BN7TCFJ4L

  Cardiac ablation percutaneous catheter
  24 reports
• EZ Steer NAV BN7TCFF4L

  Cardiac ablation percutaneous catheter
  3 reports
• EZ Steer NAV BN7TCJJ4L

  Cardiac ablation percutaneous catheter
  2 reports
• EZ Steer NAV BN7TCDD4L

  Cardiac ablation percutaneous catheter
  1 report

Recent EZ Steer NAV adverse event reports

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

• InjuryMay 8, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION AND THE PATIENT EXPERIENCED CARDIAC ARREST THAT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). AT THE END OF THE PROCEDURE, WHEN THEY REMOVED THE CATHETERS FROM THE PATIENT, THE SURFACE ECG SIGNALS ATTENUATED AND APPEARED TO BE FLAT LINED. THEY RESEATED THE ECG CABLE AND THE SIGNALS RETURNED. AT THE TIME OF THE OCCURRENCE, THEY HAD CHECKED FOR A PULSE AND THE ANESTHESIOLOGIST CONFIRMED THAT THE PATIENT DID HAVE A PULSE. THERE WAS NO INJURY TO THE PATIENT. UPDATED INFORMATION INDICATED THAT AFTER THE ABLATION PROCEDURE WAS CALLED BY THE PHYSICIAN, THE PHYSICIAN WITHDREW THE 4 CATHETERS (ABLATION RF, RV, CS, HIS) WITH THE 4MM NAVISTAR D/F AND QUAD CATHETERS FROM BWI, POLARIS - DECA FROM BOSTON SCIENTIFIC AND A CRD2 SUPREME FORM ABBOTT/ST. JUDE. A MEDTRONIC FREEZER CATHETER HAD BEEN USED FOR ONE APPLICATION WAS ALREADY REMOVED PRIOR AND WAS SITTING ON THE EXAM TABLE. IN LESS THAN 20 SECONDS OF WITHDRAWING THE CS CATHETER, THEY HAD AN EKG TRACING EVENT ON BOTH CARTO AND CARDIOLAB MONITORING SCREENS. AT FIRST, THE PHYSICIAN STATED THAT SHE DID NOT FEEL A PULSE (AT THE GROIN). THIS OC

  Patient problems: Cardiac Arrest

  MAUDE report 25129176 ↗
• InjuryApr 14, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH AN EZ STEER NAV CATHETER AND THE PATIENT EXPERIENCED HEART BLOCK THAT REQUIRED A PACEMAKER IMPLANTATION. THEY PLANNED TO ABLATE THE SLOW PATHWAY WITH A 4 MM CATHETER. AFTER 20 SECONDS OF ABLATION, THE PATIENT WENT INTO AV BLOCK. SUBSEQUENTLY, THE PATIENT RECEIVED A PACEMAKER. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS INADVERTENT ABLATION OF THE AV NODE. THE PATIENT¿S OUTCOME WAS REPORTED TO BE STABLE WITH THE PACEMAKER.

  Patient problems: Heart Block

  MAUDE report 24873510 ↗
• MalfunctionMar 18, 2026Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH AN EZ STEER CATHETER AND THE PACKAGING WAS COMPLETELY DAMAGED. THE MEDICAL TEAM CONFIRMED THAT BOTH THE OUTER AND INNER PACKAGING COVERING THE CATHETER WERE DAMAGED. THE DAMAGES WERE DISCOVERED AS THEY WERE SETTING UP FOR THE PROCEDURE. THE PROCEDURE MOVED FORWARD WITH ANOTHER CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24633157 ↗
• InjuryMar 2, 2026Patient Device Interaction Problem

  A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH EZ STEER NAV CATHETER AND THE PATIENT EXPERIENCED AV HEART BLOCK TREATED WITH PACEMAKER IMPLANTATION. THE REPORT INDICATED THAT DURING THE AVNRT PROCEDURE, THE PATIENT SUFFERED COMPLETE AV BLOCK AND NEEDED A PACEMAKER. SHORTLY BEFORE BLOCK ONLY SLOW JUNCTIONAL BEATS WERE SEEN WHICH LED THE PHYSICIAN TO BELIEVE WE WERE ON THE RIGHT TRACK TO ABLATE THE ACCESSORY PATHWAY. FROM THE MOMENT OF THE FIRST BLOCKED BEAT TO ABLATION STOP 5-10 SECONDS PASSED. DURING ABLATION THE TEMPERATURE DID NOT EXCEED 46°C AND NO IMPEDANCE RISE WAS OBSERVED. THE SURGERY WAS NOT DELAYED. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION AND ADDITIONAL INFORMATION ABOUT THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: Heart Block

  MAUDE report 24489283 ↗
• MalfunctionJan 12, 2026Signal Artifact/Noise; Overheating of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER NAV AND THE PLASTIC HAD MELTED. IT WAS REPORTED THAT THE EZ STEER NAV HAD NOISE ON DISTAL ON THE CARTO 3 SYSTEM. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CALLER ADDED THAT WHEN THEY REMOVED THE CATHETER, THEY FOUND A DEFORMATION ON THE CATHETER, AND IT LOOKED LIKE THE PLASTIC HAD MELTED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039362 ↗
• InjurySep 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING AN AFAVRT/WPW ATRIAL FIBRILLATION ATRIOVENTRICULAR REENTRANT TACHYCARDIA / WOLFF-PARKINSON-WHITE SYNDROME) ABLATION WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER, WHILE ATTEMPTING TO REGAIN TRANSSEPTAL ACCESS THE MEDICAL TEAM PERFORATED THE HEART. THE PATIENT CODED AND CPR WAS ADMINISTERED. A TRANSTHORACIC ECHO IDENTIFIED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT FULLY RECOVERED, AND THE LAST KNOWN STATUS WAS STABLE. JJMTEP PRODUCTS IN USE NGEN RF GENERATOR (UNKNOWN SERIAL NUMBER), CARTO 3 SYSTEM, EZ STEER 4MM NAV CATHETER (UNKNOWN LOT, PACKAGING DISPOSED OF), AND SOUNDSTAR GE 8 FR.

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 23075775 ↗
• InjuryAug 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT (ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA) ABLATION WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED COMPLETE HEART BLOCK. IT WAS REPORTED THAT THE PHYSICIAN ACCIDENTALLY BURNED THE AV (ATRIOVENTRICULAR) NODE AND THE PATIENT LOST CONDUCTION AND WAS IN COMPLETE HEART BLOCK. THE NGEN FOOT PEDAL WAS USED TO APPLY ABLATION DURING THE PROCEDURE AND THAT THE PHYSICIAN ACCIDENTALLY HIT THE NGEN FOOT PEDAL AFTER THE PATIENT WAS IN HEART BLOCK. THE LOSS OF CONDUCTION WAS NOTICED AND CONFIRMED ON THE INTRACARDIAC SIGNALS DISPLAYED ON THE CARTO 3 SYSTEM. THE PROCEDURE WAS ABORTED. NO MEDICAL INTERVENTION HAD BEEN PERFORMED. THE PHYSICIAN HAD SET UP FOR A PACEMAKER AND THAT THE PATIENT WAS ADVISED THAT THE PATIENT WOULD RECEIVE A PACEMAKER HOWEVER IT WAS REPORTED THAT THE CONDUCTION WAS SLOWLY RECOVERING AND COMING BACK BUT NOT FULLY. THE PATIENT WAS MOVED TO THE POST-OP AREA TO BE MONITORED AND THAT IT WOULD BE DETERMINED AT A LATER TIME IF THE PATIENT WOULD NEED A PACEMAKER. HOWEVER IT WAS REPORTED THAT THE PATIENT HAD FULLY RECOVERED AND DID NOT NEED A DEVICE. THE PHYSICIAN'S OPINION ON THE CAUSE

  Patient problems: Heart Block

  MAUDE report 22806993 ↗
• InjuryJul 14, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED DURING ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A EZ STEER NAV CATHETER AND THE PATIENT EXPERIENCED HEART BLOCK WITH HEART RATE OF 40-45 BEATS PER MINUTE TREATED WITH PACEMAKER IMPLANT AND PROLONGED HOSPITALIZATION. DURING AN AVNRT, THE PHYSICIAN COMPLETED A ROUND OF ABLATIONS OUTSIDE THE OSTIUM OF THE CORONARY SINUS. ABLATIONS STARTED AT 25 WATTS WITH A EZ STEER NAV AND INCREASED TO 30WATTS. THERE WAS A JUNCTIONAL RESPONSE INDICATING THAT THE RADIOFREQUENCY RF WAS APPLIED IN THE CORRECT LOCATION. POST ABLATION TESTING INDICATED THAT THE PATIENT REQUIRED MORE THERAPY. ABLATION WAS RESUMED AT 30 WATTS. SHORTLY AFTER THE START OF ABLATION THE PATIENT HAD A RUN OF ATRIAL TACHYCARDIA FOLLOWED BY NON-CONDUCTING VENTRICULAR BEATS SEEN ON THE SURFACE AND INTRACARDIAC SIGNALS. ABLATION WAS TERMINATED AND THE CARDIAC SIGNALS SHOWED THE PATIENT TO BE IN A 2:1 HEART BLOCK WITH A VENTRICULAR RATE OF 40 TO 45 BEATS PER MINUTE. THE PATIENT WAS PACED VIA A QUAD CATHETER IN THE RIGHT VENTRICLE FOR ABOUT 15 MINUTES TO SEE IF NORMAL CONDUCTION WOULD RETURN. AFTER 15 MINUTES THE VENTRICULAR PACING STOPPED, AND IT WAS NOTED THAT THE PATIENT WAS STILL

  Patient problems: Heart Block

  MAUDE report 22503668 ↗
• InjuryJun 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SVT (SUPRAVENTRICULAR TACHYCARDIA) ABLATION WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS AND MEDICATION. DURING AN SVT CASE, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. AFTER THE PHYSICIAN HAD GONE TRANSSEPTAL WITH A BRK NEEDLE, THE 4MM NAVISTAR¿ BI-DIRECTIONAL CATHETER WAS THEN ADVANCED INTO THE LEFT ATRIUM. THEY HAD BEEN MAPPING FOR ABOUT 30 SECONDS, WHEN IT WAS NOTICED THAT THE PATIENT'S BLOOD PRESSURE WAS "INCREASING." THE PATIENT'S SINUS RATE WAS "INCREASING" AS WELL ON THE CARTO¿ 3 AND RECORDING SYSTEM. THE PHYSICIAN DID TRY A DIFFERENT ACCESS POINT WHEN ATTEMPTING TO GAIN TRANSSEPTAL ACCESS, PRIOR TO CROSSING THE SEPTUM. THE PERICARDIAL EFFUSION WAS CONFIRMED VIA ECHO (ECHOCARDIOGRAPHY), AND THE PERICARDIAL EFFUSION WAS CONFIRMED AND LOCATED BEHIND THE LEFT ATRIUM. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS/MEDICATION, AND IT IS UNKNOWN HOW MUCH FLUID WAS REMOVED. PROTAMINE AND ATROPINE WAS ADMINISTERED TO THE PATIENT. THE PATIENT WAS REPORTED TO BE STABLE. PHYSICIAN BELIEVES PERFORATION THROUGH THE HEART COULD

  Patient problems: Cardiac Tamponade

  MAUDE report 22137690 ↗
• InjuryJun 3, 2025Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR (AV) NODE ABLATION PROCEDURE WITH AN EZ STEER NAV AND THE PATIENT EXPERIENCED PACEMAKER LEAD DISLODGEMENT THAT REQUIRED RE-IMPLANTATION OF THE PACEMAKER LEAD. IT WAS REPORTED THAT AFTER SUCCESSFULLY IMPLANTING THE PACEMAKER DEVICE IN THE PATIENT, AND AFTER THE AV NODE ABLATION WAS COMPLETED, WHEN THE PHYSICIAN WAS REMOVING THE EZ STEER NAV FROM THE BODY, THE EZ STEER NAV BECAME "CAUGHT" ON ONE OF THE PACEMAKERS LEADS IN THE PATIENT, AND THE LEAD WAS DISLODGED. THERE WAS NO CAPTURE OR MORPHOLOGY FOR THE PACEMAKER LEAD. THE MEDICAL INTERVENTION PROVIDED WAS TO RE-IMPLANT OR RE-ADD THE PACEMAKER LEAD INTO THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION; THEY WERE SLOTTED TO STAY OVERNIGHT EITHER WAY. THERE WAS NO PHYSICAL DAMAGE TO THE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22132591 ↗
• MalfunctionMay 29, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE WITH AN EZ STEER NAV FOR EXPERIENCED CONCERNING CHARRING. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT ABLATIONS WERE DELIVERED WITH A 4 MM NAV IRRIGATED CATHETER AND THEN THE NGEN SYSTEM. WE GOT GOOD BURNS WITH SETTINGS: 60 SECONDS, 60 DEGREES CELSIUS AND 50W. WE GOT GOOD BURNS REACHING POWER AND THEN WE STARTED HAVING LESIONS WITH JUST 1 W. WE CHECKED CATHETER TIP AND THERE WAS CHAR. CHAR IS A PHYSICAL PHENOMENON OF RADIOFREQUENCY ABLATION AND CAN BE A NORMAL RESULT OF THE ABLATION PROCESS. THE PRESENCE OF CHAR DOES NOT BY ITSELF REPRESENT A SERIOUS INJURY, NOR IS IT NECESSARILY THE RESULT OF A DEVICE MALFUNCTION. AS SUCH, CHAR IS NOT MDR REPORTABLE. ON 16-MAY-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING TEMPERATURE WAS AT 60C AND POWER WAS NOT GREATER THAN 10W. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PHYSICIAN DID NOT CONSIDER THE AMOUNT OF CHAR OBSERVED COULD CAUSE A POTENTIAL RISK TO THIS PATIENT, HOWEVER, DID EXPRESS CONCERN OVER THE CHARRING. BASED ON PHYSICIAN¿S CONCERN, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110677 ↗
• MalfunctionMay 29, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH AN EZ STEER NAV AND OBSERVED THAT THE GAUZE WAS "CATCHING" ON THE CATHETER. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS WIPING DOWN THE CATHETER WITH A WET GAUZE, THE GAUZE WAS "CATCHING" ON THE CATHETER. THE CATHETER HAD NOT YET BEEN INSERTED IN THE BODY. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED AND COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON 05-MAY-2025. NO SIGN OF SHARP / ROUGH EDGES. ADDITIONAL INFORMATION WAS RECEIVED ON 29-MAY-2025 WHICH CLARIFIED THAT THE PHYSICIAN STATED THAT THE GAUZE WAS CATCHING ON THE DISTAL ELECTRODE. INITIALLY SINCE THE PHYSICIAN STATED THE GAUZE WAS CATCHING, THE BIOSENSE WEBSTER, INC. REPRESENTATIVE DID NOT CHECK IT. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE REPLACED IT WITH THE SAME TYPE OF CATHETER. THE PHYSICIAN WIPED THE NEW ONE AND SAID THE NEW ONE WAS FINE. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE THEN CHECKED THE ORIGINAL EZ STEER NAV CATHETER VISUALLY AND DID NOT SEE ANYTHING UNUSUAL AND ALSO PHYSICALLY RAN HIS FINGER ON IT AND DID NOT FEEL ANYTHING LIFTED OR SHARP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110079 ↗
• MalfunctionApr 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH EZ STEER NAV FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED INTERNAL COMPONENTS EXPOSED ON THE TIP AREA. IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS BENT ONCE THE CATHETER WAS REMOVED FROM THE BODY. WHEN THE CATHETER WAS REPLACED, THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. NO WIRES WERE EXPOSED. THE DAMAGE DID NOT RESULT IN LIFTED OR SHARP RINGS. DOES NOT BELIEVE THERE WAS RESISTANCE IN INSERTING OR REMOVING THE CATHETER. BELIEVES THE ISSUE WAS ABOUT AN INCH AWAY FROM THE DISTAL TIP. DOES NOT HAVE A PICTURE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 01-APR-2025 OBSERVED INTERNAL COMPONENTS EXPOSED ON THE TIP AREA. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF INTERNAL COMPONENTS EXPOSED ON THE TIP AREA ON 01-APR-2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903316 ↗
• MalfunctionFeb 25, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A EZ STEER NAV AND WHEN THE CATHETER WAS TAKEN OUT, CHAR WAS NOTED TO HAVE ADHERED TO THE TOP (TIP ELECTRODE). THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES. THE PHYSICIAN CONSIDERED THE CHAR AS ¿BIG¿, AND THEY HAD NO IDEA THERE WAS CHAR. HE DID AN ULTRASOUND AND DID NOT SEE IT IN THE ATRIUM. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21465385 ↗
• MalfunctionJan 2, 2025Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Output below Specifications; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Output below Specifications

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER NAV AND AN EXCESSIVE CHARRING ISSUE OCCURRED. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT WITHIN 1-2 ABLATION LESIONS THE SMARTABLATE GENERATOR DISPLAYED A LOWER WATTAGE. THE CALLER STATED THAT THE CATHETER WAS REMOVED AND CHAR WAS NOTED ON THE END OF THE CATHETER. THE CALLER STATED THAT DEBRIS WAS REMOVED FROM THE CATHETER AND ADVANCED INTO THE PATIENT AGAIN. THE CALLER STATED THAT WITHIN 1-2 ABLATION LESIONS OF ABOUT 10 SECONDS EACH, THE ISSUE OCCURRED AGAIN. THE CALLER STATED THAT THEY WERE USING A "REASONABLE BURN METHODOLOGY". THE PRESENCE OF CHAR DOES NOT BY ITSELF REPRESENT A SERIOUS INJURY, NOR IS IT NECESSARILY THE RESULT OF A DEVICE MALFUNCTION. AS SUCH, CHAR IS NOT MDR REPORTABLE. ON 12-DEC-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO ERRORS DISPLAYED ON THE NGEN OR CARTO. THE PHYSICIAN NOTICED THE ISSUE WHEN CONTINUOUSLY GETTING MAXIMUM TEMPERATURE SETTINGS AT LOW WATTS DURING ABLATIONS. THE NGEN GENERATOR WAS USED ON THE 4MM PROTOCOL SETTING WITH THE ABLATION SETTINGS SET AT 60 SECONDS, 50 WATTS, AND 55 DEGREES. H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063195 ↗

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