EZ Steer NAV BN7TCDF4LRecalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10846835002997), received between Sep 6, 2016 and May 8, 2026 — classified as 2 deaths, 75 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (34 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 105 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 22, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT (ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WHEN DEFLECTING THE CATHETER IN THE BODY, THE CATHETER'S TIP WAS BENDING TOO FAR. THE CATHETER WAS TAKEN OUT OF THE BODY. NO PART OF THE CATHETER WAS STUCK IN THE PATIENT'S BODY. WHEN THE CATHETER WAS REPLACED, THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20760425 ↗
• MalfunctionNov 13, 2024Contamination /Decontamination Problem; Output below Specifications; Contamination /Decontamination Problem; Output below Specifications

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE POWER DISPLAYED ON THE CARTO 3 SYSTEM AND SHOWED THAT THE SMARTABLATE GENERATOR WASN'T REACHING ITS TARGET. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE MEDICAL TEAM THEN NOTED THAT THE FIRST CATHETER HAD A VISUAL DEFECT. THERE WAS 'GLUE' OVER ONE OF THE CATHETER SENSORS. NO RESISTANCE WAS NOTED WHEN WITHDRAWING THE CATHETER. NO LIFTED OR SHARPENED RINGS WERE NOTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677123 ↗
• InjuryOct 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AVNRT (ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA) ABLATION AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION. INTERVENTION IS UNKNOWN BUT A "CODE" WAS CALLED. AFTER AN AVNRT CASE, A PERICARDIAL EFFUSION WAS NOTICED. THE PATIENT¿S BLOOD PRESSURE DROPPED IN THE WAITING ROOM AND ¿THEY CALLED A CODE ON THE PATIENT.¿ THE MEDICAL INTERVENTION PROVIDED WAS UNKNOWN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN COULD NOT CONFIRM WHAT CAUSED THE PERICARDIAL EFFUSION.

  Patient problems: Cardiac Tamponade

  MAUDE report 20453389 ↗
• MalfunctionSep 20, 2024Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Material Twisted/Bent; Output below Specifications; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Material Twisted/Bent; Output below Specifications

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH EZ STEER NAV AND AN EXCESSIVE CHARRING ISSUE OCCURRED. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT ABLATION LIMITED IN POWER (TARGET TEMPERATURE REACHED BUT POWER AROUND 10-15W DESPITE A TARGET OF 60W). DEPOSIT FORMATION QUICKLY AFTER THE START OF ABLATION AT THE TIP OF THE CATHETER (TYPE "CARBON"). DEPOSIT REMOVED 2 TIMES. CHANGING THE CATHETER SOLVED THIS PROBLEM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED INITIAL REPORTED LOW POWER AND CHAR WERE NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT THESE COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 10-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SYSTEM DIDN¿T PRESENT ANY MESSAGE. THE PHYSICIAN REPORTED A PROBLEM OF CHAR ON THE DISTAL PART OF THE CATHETER AND POWER LIMITATION. VISUALLY, THE CATHETER WAS A LITTLE BIT KINKED ON THE DISTAL PART OF THE CATHETER. NO ANTICOAGULATION AS IT WAS ON THE RIGHT ATRIUM. ADDITIONALLY, THE PHYSICIAN CONSIDER THAT THE CHAR WAS EXCESSIVE BUT THERE WAS NO RISK TO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20274845 ↗
• MalfunctionAug 22, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SVT (SUPRAVENTRICULAR TACHYCARDIA) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A BROKEN TIP. DURING THE PROCEDURE, THE PHYSICIAN STATED THAT THE CATHETER WAS NO LONGER DEFLECTING. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043049 ↗
• InjuryApr 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND DURING THE ABLATION PHASE, THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. FIRST IT WAS REPORTED THAT THE DISTAL ELECTRODE ON THE EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WAS BLACKED OUT ON THE CARTO® 3 SYSTEM AND THE DISTAL SIGNAL HAD A LOT OF NOISE DISPLAYED ON BOTH CARTO® 3 AND RECORDING SYSTEMS. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON IC, BS, OR ALL ECG (BS + IC) CHANNELS JUST ON ABLATION DISTAL. THE PHYSICIAN HAD INTACT ECG SIGNAL AVAILABLE TO MONITOR THE PATIENT'S HEART RHYTHM. THE CUSTOMER¿S REPORTED NOISE ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE RISK TO THE PATIENT IS LOW. IT WAS ALSO REPORTED THAT DURING ABLATION WITH THE SECOND EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER, A STEAM POP WAS HEARD. THERE WAS NO RISE IN THE IMPEDANCE AND ABLATION STOPPED. AN IMPEDANCE SPI

  Patient problems: Cardiac Tamponade

  MAUDE report 19122725 ↗
• MalfunctionApr 10, 2024Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE 4MM NAV CATHETER HAD A STRANGE PLASTIC FILM ON THE PLASTIC TIP. THE PHYSICIAN WAS PULLING PIECES OFF THE TIP AND BLOOD AND OTHER SUBSTANCES WERE STICKING TO IT. THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED WITH NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS NOT NOTICED BEFORE USE. THE CATHETER WAS NOT ADVANCING VERY FAR UP THE SHEATH AND SO IT WAS PULLED OUT TO BE INSPECTED AND THEY NOTICED WHAT SEEMED LIKE A PLASTIC COATING OR FILM AROUND THE TIP OF THE ABLATION CATHETER. SOME OF THE MATERIAL WAS PULLED OFF AND THE REST SEEMED TO BE ADHERED TO THE TIP BUT COULD BE SLID UP AND DOWN A BIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078479 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE CATHETER TIP WAS DISLOCATED. IT WAS REPORTED THAT THE TIP OF THE CATHETER LOOKED DISLOCATED ON THE FLOURO MACHINE. THE CALLER TOOK THE CATHETER OUT OF THE BODY AND THE TIP WAS DISLOCATED. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. NO WIRES WERE EXPOSED. THERE WAS NO DAMAGE THAT RESULTED IN LIFTED OR SHARP RINGS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976388 ↗
• InjuryFeb 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA (AVNRT) CARDIAC ABLATION PROCEDURE WHICH INCLUDED AN EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC HEART BLOCK TREATED WITH IMPLANTATION OF PACEMAKER AND EXTENDED HOSPITALIZATION. THE PATIENT WAS MILDLY SEDATED WITH PROPOFOL. THERE WAS THE TEAM OF ANESTHESIOLOGISTS IN CHARGE OF THE SEDATION OF THE PATIENT. THE CASE STARTED AND THE PHYSICIAN PLACED THE DECANAV CATHETER IN THE CORONARY SINUS (CS), AND RIGHT VENTRICLE (RV) CATHETER (NON-BIOSENSE), AND THE 4MM ABLATION CATHETER (EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER). THE ELECTROPHYSIOLOGY (EP) STUDY WAS PERFORMED, AND IT WAS DECIDED TO PERFORM AN AVNRT ABLATION. THE PHYSICIAN FIRST MARKED HIS POINTS AND THEN MARKED WITH A POINT A GOOD LOCATION FOR ABLATION. DURING THIS PROCESS, THE PATIENT WAS MOVING THE LEGS. TWO ASSISTANT DOCTORS TRIED TO MAINTAIN THE BODY AND LEGS (WITHOUT MOVING) BY HOLDING THEM. THE PHYSICIAN PERFORMED SEVERAL ABLATIONS. THE LAST ABLATION LASTED FOR 20S, DURING WHICH THERE WAS SOME SLOW JUNCTIONAL BEATS WHICH SHOWED THAT THE ABLATION WAS BEING PERFORMED IN THE S

  Patient problems: Heart Block

  MAUDE report 18802883 ↗
• InjuryOct 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A INTRANODAL REENTRY ABLATION PROCEDURE WITH A NAVI-STAR¿ RMT ELECTROPHYSIOLOGY CATHETER AND THE PATIENT SUFFERED WITH COMPLETE ATRIOVENTRICULAR BLOCK. THE PATIENT CAME FOR AN INTRANODAL REENTRY PROCEDURE. THE CATHETER USED WAS A 4MM NAV. THE PATCHES WERE WELL POSITIONED AND BREATHING WAS WELL CAPTURED BY THE ACCURESP MODULE. THE PRACTITIONER USED THE ABLATION SETTINGS ON THE GENERATOR RECOMMENDED FOR THIS TYPE OF CATHETER. HOWEVER, THE PATIENT EMERGED FROM THE PROCEDURE WITH COMPLETE ATRIOVENTRICULAR BLOCK WHICH WAS CONFIRMED OVER THE FOLLOWING DAYS. THERE WERE NO PRODUCT PROBLEMS REPORTED.

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 17935951 ↗
• InjurySep 29, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT RECEIVING A CARDIAC ABLATION PROCEDURE INCLUDING USE OF EZ STEER NAVIGATIONAL 4MM CATHETER EXPERIENCED CARDIAC TAMPONADE AND REQUIRED PERICARDIOCENTESIS. IT WAS REPORTED THAT A PERICARDIAL EFFUSION WAS NOTICED AFTER THE PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT'S BLOOD PRESSURE DROPPED A LOT. AFTER COMING FROM SEDATION, THE PATIENT COMPLAINED OF JAW PAIN. THE CALLER REPORTED THAT THE PERICARDIAL EFFUSION WAS CONFIRMED WITH AN EXTERNAL ULTRASOUND PROBE. THE PERICARDIOCENTESIS WAS PERFORMED AND THAT AT LEAST 180 ML OF FLUID WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN WAS OUT OF THE NORMAL QUAD CATHETERS THAT HE USUALLY USES AND THE PHYSICIAN USED A WOVEN NON-BWI CATHETER DURING THE PROCEDURE INSTEAD. THE PHYSICIAN NOTICED THAT THE WOVEN NON-BWI CATHETER WAS STIFF WHEN USING IT INSIDE THE PATIENT AND THAT THE PHYSICIAN THOUGHT THAT A PERFORATION AND PERICARDIAL EFFUSION WERE CAUSED BY THE WOVEN NON-BWI CATHETER. THE MEDICAL TEAM HAD TO CARDIOVERT THE PATIENT 3 TIMES AND THAT THE PHYSICIAN BELIEVED THE WOVEN NON-BWI CATHETER POKED THROUGH DURING ONE OF THE CARDIOVERSIONS. PER INTERNAL REVIEW, IT

  Patient problems: Cardiac Tamponade

  MAUDE report 17841470 ↗
• InjuryAug 9, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AVNRT (ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA) ABLATION THAT INCLUDED NAVISTAR CATHETER. THE PATIENT EXPERIENCED THIRD DEGREE AV BLOCK THAT REQUIRED PROLONGED HOSPITALIZATION. TIMING: DURING ABLATION. DESCRIPTION OF HEALTH HAZARD: HEART BLOCK. IT WAS REPORTED BY THE CALLER, A CLINICAL ACCOUNT SPECIALIST, THAT A THIRD-DEGREE HEAT BLOCK WAS DISCOVERED DURING ABLATION. THE CALLER STATED THAT THE PATIENT WAS WOKEN UP FROM ANESTHESIA AND APPROPRIATE DRUGS WERE GIVEN. THE PATIENT IS NOW IN OBSERVATION, THERE IS SOME FIRING RIGHT NOW, BUT WILL BE STAYING OVERNIGHT FOR OBSERVATION. IF NOT BETTER A PACEMAKER WILL BE PUT IN TOMORROW. THE PATIENT IS IN STABLE CONDITION AT THIS TIME. PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT: PROCEDURE, PATIENT CONDITION. INTERVENTION PROVIDED: PERMANENT PACEMAKER IMPLANT. OUTCOME OF EVENT: WORSENED, DURING PMI PATIENT HAD A LEAD PERFORATION EVENTUALLY REQUIRING A CENTESIS. LEAD FELL OUT OF POSITION AND REQUIRED REPOSITIONING. PATIENT POTENTIALLY HAS PERICARDITIS. SUBSEQUENT AFIB NOTED ON MONITOR. GENERATOR INFORMATION: SMARTABLATE, M490002, G4C-0562. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT R

  Patient problems: Heart Block; Pericarditis

  MAUDE report 17494922 ↗
• MalfunctionAug 8, 2023Tear, Rip or Hole in Device Packaging; Detachment of Device or Device Component; Packaging Problem; Tear, Rip or Hole in Device Packaging; Detachment of Device or Device Component; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND A PACKAGE DAMAGE ISSUE OCCURRED. IT WAS REPORTED THAT THE 4MM CATHETER PACKAGING WAS A LITTLE DAMAGED ON THE OUTSIDE. THE BOX SEEMED CRUSHED AND WHEN THEY OPENED THE BOX, THE CATHETER INSIDE WAS CRUSHED AND THERE WAS A HOLE IN THE OUTER BARRIER OF THE CATHETER. THE CATHETER WAS NEVER OPENED FROM THE STERILE PACKAGING DUE TO THE CRUSHED HANDLE. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484848 ↗

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