EnSite™ ENSITE-DWS-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 05415067032171), received between Jan 7, 2021 and Mar 25, 2026 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Output Problem

  DURING THE ATRIAL FIBRILLATION (PFA) PROCEDURE, OUTPUT ISSUES WITH THE DWS RESULTED IN A PROCEDURAL DELAY. AFTER POWER-ON, A PASSWORD ENTRY SCREEN WITH AN UNUSUAL KEY ICON APPEARED. NO MATTER WHAT WAS ENTERED, THE SCREEN RETURNED, AND THE PROCESS COULD NOT PROCEED. RESTARTING DID NOT RESOLVE THE ISSUE. NO USB DEVICES WERE CONNECTED, AND THE SAME SCREEN APPEARED EVEN WHEN BOOTING IN THIS STATE. FURTHERMORE, THE SAME SCREEN APPEARED AND THE PROCESS COULD NOT PROCEED EVEN WHEN THE KEYBOARD AND MOUSE WERE DISCONNECTED AND ONLY ONE DISPLAY WAS CONNECTED. FIVE RESTARTS WERE PERFORMED, BUT NO IMPROVEMENT WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING NON-ABBOTT (CARTO) AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686838 ↗
• MalfunctionJan 13, 2025Output Problem; Output Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE FOR ATRIAL FIBRILLATION, AN ERROR OCCURRED RESULTING IN CANCELLATION OF THE PROCEDURE. THERE WAS AN ERROR DISPLAYED ON THE DWS WHEN THE CATHETER WAS CONNECTED IN PORT 7 OR 8; "UNEXPECTED ERROR OCCURRED. APPLICATION EXITED". THE CATHETER AND THE CABLES WERE REPLACED TWICE. THE AMPLIFIER AND DWS WERE RESTARTED MULTIPLE TIMES WITH NO RESOLUTION. WHEN THE CABLE WAS CONNECTED TO THE CATHETER THE ISSUE CONTINUED. THE PROCEDURE WAS THEN CANCELLED WITH NO ADVERSE PATIENT CONSEQUENCES. LATER, REPLACING THE DWS RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143097 ↗
• MalfunctionSep 5, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. THERE WERE ISSUES WITH THE ENSITE X SYSTEM. AT TIMES IT WAS NOT POSSIBLE TO SELECT ANYTHING USING LEFT CLICK, AND THE DWS WAS RESTARTED TO RESOLVE THE ISSUE. AT ONE MOMENT, GEOMETRY WAS UNABLE TO BE EDITED DUE TO A LACK OF FUNCTIONALITY OF THE LEFT CLICK, AND SHORT CUTS WERE NOT FUNCTIONING. THE AMPERE GENERATOR AND DWS DISCONNECTED WHEN ABLATING. RESTARTING THE DWS AGAIN RESOLVED THE ISSUE. THE DWS HAD ISSUES EACH TIME SOMETHING WAS DISCONNECTED OR CONNECTED, OR WHEN VALIDATION OR DISTORTION WAS PERFORMED. THE DWS WAS RESTARTED AT LEAST 4 TIMES THROUGHOUT THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145683 ↗
• MalfunctionSep 4, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, COMMUNICATION ISSUES RESULTED IN A PROCEDURAL DELAY. THERE WERE ISSUES WITH THE ENSITE X SYSTEM. AT TIMES IT WAS NOT POSSIBLE TO SELECT ANYTHING USING LEFT CLICK, AND THE DWS WAS RESTARTED TO RESOLVE THE ISSUE. AT ONE MOMENT, GEOMETRY WAS UNABLE TO BE EDITED DUE TO A LACK OF FUNCTIONALITY OF THE LEFT CLICK, AND SHORT CUTS WERE NOT FUNCTIONING. THE AMPERE GENERATOR AND DWS DISCONNECTED WHEN ABLATING. RESTARTING THE DWS AGAIN RESOLVED THE ISSUE. THE DWS HAD ISSUES EACH TIME SOMETHING WAS DISCONNECTED OR CONNECTED, OR WHEN VALIDATION OR DISTORTION WAS PERFORMED. THE DWS WAS RESTARTED AT LEAST 4 TIMES THROUGHOUT THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137148 ↗
• MalfunctionSep 4, 2024Unexpected Shutdown; Unexpected Shutdown

  DURING THE PROCEDURE, AN UNEXPECTED SHUTDOWN OCCURRED CAUSING A DELAY. AFTER 15 MINUTES OF MAPPING WITH THE ADVISOR HD GRID, THE SYSTEM FROZE AND IT WAS NOT POSSIBLE TO USE THE MOUSE OR KEYBOARD; NO ERROR MESSAGES WERE NOTED. AN ATTEMPT TO HIT CTRL+ALT+DEL DID NOT RESOLVE THE ISSUE. THE DWS ATTEMPTED TO REBOOT ITSELF WITHOUT SUCCESS. ATTEMPTS TO REBOOT THE DWS THREE TIMES WERE UNSUCCESSFUL. THE DWS WAS THEN FORCED TO SHUT DOWN BY PUSHING THE ON/OFF BUTTON FOR FIVE SECONDS, AND ALL CABLES CONNECTED TO THE DWS WERE DISCONNECTED AND RECONNECTED AND THE STUDY RESUMED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135769 ↗
• MalfunctionAug 27, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING PREPARATION FOR AN ATRIAL FIBRILLATION PROCEDURE, A COMMUNICATION ISSUE OCCURRED AND THE PROCEDURE WAS CANCELLED. WHILE THE PATIENT WAS ON THE TABLE UNDER GENERAL ANESTHESIA, IT WAS REPORTED THAT THERE WAS NO CONNECTION BETWEEN AMPLIFIER AND DWS; THE GREEN LED WAS BLINKING. RESTARTED SEVERAL TIMES AND CHANGED THE FIBER OPTIC TWO TIMES. IT WAS MENTIONED THAT THE SMALL GREEN TRIANGLE AT THE BACK OF THE AMPLIFIER WAS ON, USUALLY MEANING THAT COMMUNICATION IS GOOD. ADDITIONALLY, A RED LIGHT WAS VISIBLE IN THE FO WHEN UNPLUGGING IT. EVERYTHING FROM THE AMPLIFIER WAS REMOVED BEFORE TRYING TO REBOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078379 ↗
• MalfunctionOct 10, 2023Output Problem; Output Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, AN OUTPUT PROBLEM OCCURRED CAUSING A PROCEDURE DELAY. AN ISSUE WAS NOTED WITH THE ADVISOR HD GRID CATHETER WHEN USING ENSITE X (V2.0.1) IN VOXEL MODE. AFTER CONNECTING THE CATHETER TO THE ENSITE X MAPPING SYSTEM EVERYTHING WORKED AS EXPECTED. WHEN THE MAPPING WAS FINISHED IN THE RIGHT ATRIUM, THE CATHETER WAS WITHDRAWN INTO THE INFERIOR VENA CAVA. THE CATHETER WAS OUTSIDE THE SHEATH. AFTER THAT, THERE WAS A RED DOT AT THE MAGNETIC SENSOR INDICATOR AND THE DIAGNOSTIC CATHETERS WERE NOT VISIBLE. THE PRS SENSORS WERE CORRECTLY SHOWN IN GREEN COLOR, WITH NO DISTORTION. THE CATHETER WAS RETURNED TO THE RIGHT ATRIUM, AND SIGNALS WERE SEEN FROM ALL THE CATHETER ELECTRODES BUT STILL A RED DOT AT THE MAGNETIC SENSOR INDICATOR. THE CATHETER CABLE WAS REPLACED WITH NO RESOLUTION. THE AMPLIFIER WAS REBOOTED, THE POSITION OF MAGNETIC FRAME WAS MOVED A BIT, AND THE DWS WAS REBOOTED BUT THE ISSUE DID NOT RESOLVE. WHEN THE STUDY WAS RESUMED, THERE WAS AN ERROR ON THE DWS ¿AN ACTIVE ENGUIDE IS REQUIRED TO RESUME A STUDY¿. THE CATHETER WAS REPLACED BUT THE ISSUE REMAINED. A NEW STUDY WAS STARTED WITH THE NEW CATHETER AND THE CASE WAS COMPLETED WITH NO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908256 ↗
• MalfunctionJun 29, 2023Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THE CATHETERS COULD NOT BE CONNECTED WHICH CAUSED A DELAY. THE MAPPING CATHETER WAS RECOGNIZED UPON REINSERTION, BUT THE ABLATION CATHETER WAS NOT. THE AMPLIFIER AND ENSITE SYSTEM WERE RESTARTED, THE CABLE WAS RECONNECTED AND THE CATHETER WAS REPLACED WHICH DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS STOPPED FOR MORE THAN 30 MINUTES AND WAS THEN RESTARTED BY CHANGING FROM VOXEL MODE TO NAVX MODE. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE ENSITE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17230841 ↗
• MalfunctionJun 28, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING A PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE THERE WERE MAPPING ISSUES WHICH RESULTED IN A DELAY. WHILE USING THE ENSITE X IN NAVX MODE, IT WAS NOTED THAT WHEN ADDING GEOMETRY WITH THE TACTIFLEX SE ABLATION CATHETER AFTER THE RVOT GEOMETRY WAS CREATED AND SENSOR ENABLED CORRECTION WAS DONE THE GEOMETRY BECAME THIN. THE NAVX COMPENSATION WAS USED AGAIN, CAUSING MODEL BLOAT. CHANGING BACK TO SENSOR ENABLED COMPENSATION, THE GEOMETRY BECAME THIN AGAIN. WHEN PACING WITH TACTIFLEX SE ABLATION CATHETER, SENSING WAS NOT PERFORMED PROPERLY, AND PACING COULD NOT BE PERFORMED. THE IMPEDANCE OF THE TACTIFLEX SE ABLATION CATHETER WAS HIGH, AND THE FLUCTUATION OF THE BASELINE WAS INTENSE EVEN IN THE GENERATOR WAVEFORM. THE TACTIFLEX SE ABLATION CATHETER WAS REPLACED WITH A NEW TACTIFLEX SE ABLATION CATHETER, AND THE PACING ISSUE WAS RESOLVED. HOWEVER, THE GEOMETRY ISSUE PERSISTED, SO THE TACTIFLEX SE ABLATION CATHETER WAS REPLACED WITH A TACTICATH SE ABLATION CATHETER. HOWEVER, THE ISSUE STILL PERSISTED, SO THE SECOND TACTIFLEX SE ABLATION CATHETER WAS EVENTUALLY USED TO PERFORM THE RF DELIVERY. IT WAS "THOUGHT" THAT REPLACING THE AMPLIFIER RESOLVED THE ISSUE, HOWEVER NO PERFORMANCE IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218520 ↗
• MalfunctionJun 16, 2023Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

  ADDITIONAL INFORMATION: THIS REPORT IS TO ADDRESS THE UPDATED ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17143547 ↗
• MalfunctionMay 17, 2023Erratic or Intermittent Display; Erratic or Intermittent Display

  DURING THE PREMATURE VENTRICULAR CONTRACTION PROCEDURE, DISPLAY ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOTED THAT THE CATHETER WAS FLASHING RED AND FREEZING. THE CATHETER WAS EXCHANGED, WITH NO RESOLUTION. THE MAPPING CATHETER WAS USED AT THE SAME TIME AND HAD THE SAME ISSUE AS THE ABLATION CATHETER. THE ISSUE COULD NOT BE RESOLVED AND THE PROCEDURE WAS CANCELLED. THERE ARE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946016 ↗
• MalfunctionMar 19, 2023Output Problem; Output Problem

  DURING THE PULMONARY VEIN ISOLATION PROCEDURE, IT WAS REPORTED THAT THE SYSTEM WAS SLOW AND UNABLE TO MAP SMOOTHLY AND THERE WERE SEVERAL MESSAGES THAT APPEARED DURING SYSTEM BOOTUP. THE COMPUTER WAS REBOOTED AND SWITCHED TO VOXEL MODE, BUT THE ISSUE DID NOT RESOLVE. THE PROCEDURE WAS ABANDONED WITH NO ADVERSE PATIENT CONSEQUENCES, AND SUBSEQUENTLY COMPLETED LATER. THE DWS WAS REPLACED AND THE RELEVANT SOFTWARE AND MODULES WERE INSTALLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570582 ↗
• MalfunctionFeb 22, 2023Communication or Transmission Problem; Communication or Transmission Problem

  RELATED MANUFACTURING REFERENCE: 2184149-2023-00036. DURING THE PROCEDURE, IT WAS NOTED THERE WERE SENSOR CONNECTION AND COMMUNICATION ISSUES WHICH CAUSED THE PROCEDURE TO BE CANCELED. IT WAS NOTED THAT BOTH TACTICATH SE CATHETER AND THE ADVISOR VL CATHETER STARTED LOSING SENSOR CONNECTION AND LOCKING UP EARLY IN THE CASE, PROGRESSIVELY WORSENING AND BECOMING MORE FREQUENT. BOTH CATHETERS WERE REPLACED, THE ADVISOR VL CABLE WAS REPLACED, FIELD FRAME WAS ADJUSTED, FIELD FRAME CABLE WAS REPLACED, AND FIELD FRAME WAS REPLACED, ALL WITHOUT RESOLVING THE ISSUES. THE PHYSICIAN WAS NOT ABLE TO SAFELY CONTINUE ABLATING AND STOPPED WITHOUT COMPLETING THE REST OF THE PROCEDURE. NO PATIENT CONSEQUENCES KNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421815 ↗
• MalfunctionDec 21, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, THERE WAS A SHIFT OBSERVED WITH THE ABLATION CATHETER RESULTING IN A DELAY OF PROCEDURE BY AN HOUR. THE PATCHES WERE VALIDATED WHEN EVERY CATHETER WAS INSERTED INTO THE HEART, AND THEN THE RESPIRATORY COMPENSATION WAS TAKEN WHICH DELAYED THE PROCEDURE BY AN HOUR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030336 ↗
• MalfunctionNov 15, 2022Computer Software Problem; Application Program Problem; Output Problem; Computer Software Problem; Application Program Problem; Output Problem

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT (AVNRT) ABLATION PROCEDURE, THE SYSTEM FROZE WHICH CAUSED A DELAY IN THE PROCEDURE. THE MAPPING SYSTEM WAS WORKING DURING GEOMETRY COLLECTION AND DURING THE EP STUDY. IT DID NOT WORK AFTER THE ABLATOR WENT IN AND WAS BEING POSITIONED FOR THE SLOW PATHWAY ABLATION. THE SYSTEM FROZE AND AN ERROR MESSAGE AND WARNING WERE NOTED STATING: ¿FAILED TO CREATE PATH.' AND THE MESSAGED COULD NOT BE CLOSED. THE SYSTEM THEN WENT OUT TO THE MAIN SCREEN AND AN ATTEMPT TO ENTER THE LAST STUDY SHOWED AN ERROR MESSAGE STATING THE PATH FAILED. IT WAS THEN TRIED TO ENTER A NEW STUDY UNDER THE SAME PATIENT AND, AGAIN THIS DID NOT WORK. THE DWS WAS RESTARTED 5 TIMES AND WAS LEFT TURNED OFF FOR 30 MINUTES, BUT THE COMPUTER DID NOT RESTART PROPERLY. THE COMPUTER THEN BROUGHT UP THE 'ENTER LUKS PASSWORD' SCREEN AND PROMPTED TO CHECK IF A USB DEVICE WAS ATTACHED. THERE WAS NO USB DEVICE PLUGGED IN OR CD IN THE DRIVE. THE LUKS PASSWORD WAS ENTERED, ALLOWING LOG IN BUT WAS UNABLE TO START A CASE UNDER THIS LOG IN, SO IT WAS RESTARTED TO LOG IN PROPERLY AND THE SAME LUKS PASSWORD SCREEN APPEARED. THE CASE CONTINUED WITHOUT THE AID OF MAPPING. ABLATION WAS PERFORMED USI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15797908 ↗
• InjuryOct 21, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  RELATED MANUFACTURING REF: 2184149-2022-00255. DURING THE ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL PERFORATION OCCURRED AFTER AN ISSUE WITH THE PRS-P SENSORS CHANGING POSITIONS DUE TO PATIENT COUGHING AND BODY MOVEMENT WHILE MAPPING IN THE LEFT ATRIUM. DUE TO THE CHANGE IN POSITION OF THE SENSORS THE SYSTEM COULD NOT COLLECT ANY INFORMATION SUCH AS GEOMETRY. THE SENSORS ON THE PATIENT'S BACK WERE THEN FIXED WITH ADHESIVE, BUT AFTER THIS THE PATIENT BECAME HYPOTENSIVE AND A PERFORATION WAS FOUND IN THE LEFT ATRIUM VIA AN ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABLE WHEN THE CASE WAS CANCELLED. THE PHYSICIAN ALLEGES THE ISSUE WAS DUE TO THE BAD PERFORMANCE OF THE SYSTEM.

  Patient problems: Cardiac Perforation

  MAUDE report 15651249 ↗
• MalfunctionOct 11, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE ATRIAL TACHYCARDIA PROCEDURE, THE AMPLIFIER AND DWS WERE NOT COMMUNICATING WHICH CAUSED A DELAY IN THE PROCEDURE. THE ENSITE X WAS SET UP AND THE AMPLIFIER AND THE DWS WERE SWITCHED ON. EVERYTHING WAS WORKING, BUT THE SYSTEM WARNED THAT THE FIELD FRAME WAS NOT CONNECTED. THE AMPLIFIER WAS SWITCHED OFF, THE FIELD FRAME WAS CONNECTED, AND THE AMPLIFIER WAS SWITCHED ON AGAIN. THE AMPLIFIER AND DWS WERE REBOOTED A FEW TIMES, EVERYTHING ON THE FRONT OF THE ENSITE X WAS UNPLUGGED, AND THE OPTIC FIBER WAS REPLACED WITH NO RESOLUTION. THE GREEN LED WAS STILL FLASHING AFTER A SUCCESSFUL AUTO-TEST. THE ENSITE X WAS SWITCHED OFF, THE POWER CORD WAS EXCHANGED, THE MAGNETIC FIELD FRAME WAS UNPLUGGED, AND THE DWS WAS TURNED OFF. THE DWS WAS THEN RESTARTED, AND THE AMPLIFIER WAS TURNED ON. HOWEVER, THE GREEN LIGHT WAS STILL BLINKING. EVERYTHING WAS THEN UNPLUGGED AND SWITCHED OFF. THE THREE SMALL DONGLES THAT CONNECT THE TACTISYS TO THE ENSITE X, AMPERE TO ENSITE X, AND DWS TO ENSITE X WERE REMOVED. THE ENSITE X AND DWS WERE THEN RESTARTED, WHICH RESOLVED THE ISSUE. THE CONNECTION WAS SUCCESSFUL, AND THE GREEN LIGHT WAS NO LONGER BLINKING. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580540 ↗
• MalfunctionSep 8, 2022Output Problem; Output Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THERE WAS A DELAY DUE TO A SYSTEM ERROR. WHEN THE STUDY WAS FINISHED, RESUME STUDY ATTEMPTED TO PERFORM, BUT AN ERROR MESSAGE "A NON-RECOVERABLE SYSTEM ERROR WILL CAUSE THE STUDY TO SHUT DOWN IMMEDIATELY. RESUME THE STUDY, OR START A NEW STUDY." WAS DISPLAYED. WHEN RESTARTING WITH NEW STUDY WITH THE SAME PATIENT NAME AND ID AND PRESSED BEGIN STUDY, THE SAME MESSAGE WAS DISPLAYED AGAIN. ONCE RESTARTING DWS AND AMPLIFIER AND STARTING A NEW STUDY WITH A DIFFERENT ID, THE STUDY WAS STARTED. THE THREE CATHETERS WERE EXCHANGED BECAUSE IT WAS STARTED WITH A DIFFERENT ID. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE SYSTEM AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381316 ↗
• MalfunctionJul 5, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE USING ENSITE X IN VOXEL MODE, THE PROCEDURE WAS CANCELLED DUE TO THE FOLLOWING ISSUES OF DISPLAY, MODEL BLOAT, RESPIRATION COMPENSATION, AND METAL DISTORTION WAS TOO SENSITIVE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14912454 ↗
• MalfunctionApr 8, 2022Power Problem; Power Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE SYSTEM WAS POWERED ON, THE LUKS PASSWORD SCREEN WAS DISPLAYED. THE USB PORT AND DVD DRIVE WERE EMPTY. THE "ENTER" WAS PRESSED ON THE ENSITE WITH NO RESOLUTION. THE SYSTEM WAS POWER CYCLED SEVERAL TIMES TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14053222 ↗
• MalfunctionMar 24, 2022Display or Visual Feedback Problem; Electromagnetic Interference; Application Program Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Electromagnetic Interference; Application Program Problem; Communication or Transmission Problem

  DURING AN ENSITE X PULMONARY VEIN ISOLATION AND TYPICAL FLUTTER WITH ENSITE X IN NAVX AND VOXEL MODE, A PROLONGED PROCEDURE OCCURRED. ALL THE CATHETER AND THE GUIDEWIRE WERE PLACED IN NON-FLUORO MODE AND A MODEL WAS TAKEN OF THE RIGHT ATRIUM AND CORONARY SINUS IN NAVX MODE. IN NAVX MODE, THERE WAS A LOT OF RESPIRATION RELATED CATHETER MOVEMENT AND A MAP SHIFT OCCURRED. THE ENSITE X'S MAGNETIC FIELD IS INTERFERING WITH THE DEFIBRILLATOR. WHEN THE MAGNETIC FIELD IS SWITCHED ON, THE DEFIBRILLATOR PERCEIVES INTERFERING SIGNALS. THE MESSAGE APPEARED: "NECK PATCH NOT CONNECTED". WHEN CHECKING ALL PATCHES, THEY WERE ALL CORRECTLY GLUED AND CONNECTED. THE CHANGE WAS MADE FROM NAVX TO VOXEL MODE FOR A FULL IMPEDANCE INTEGRATION IN VOXEL MODE. IN VOXEL MODE, IT WAS DIFFICULT TO CREATE A MAP, BECAUSE THE MAPPING CATHETER WAS FREQUENTLY IN LOW CONFIDENCE AND TEMPORARILY FROZE. THE CS CATHETER WAS NOT CORRECTLY DISPLAYED, BECAUSE OF LOW CONFIDENCE AND EXCESSIVE MODEL BLOATING LED TO UNCERTAINTY. THE STUDY WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891329 ↗
• MalfunctionMar 24, 2022Display or Visual Feedback Problem; Application Program Problem; Display or Visual Feedback Problem; Application Program Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE IN VOXEL MODE, DIFFICULTY WAS NOTED RECORDING THE ANATOMY AND A DELAY OCCURRED. MAPPING HAD TO BE DONE IN THE TWO LOWER VEINS BECAUSE POINTS COULD NOT BE COLLECTED WITH THE CATHETER IN THE VEINS. EDITING THE MAP TOOK EXTRA TIME DUE TO MODEL BLOATING. IRREGULAR RESPIRATION HAD TO BE SWITCHED OFF, OTHERWISE POINTS WOULD NOT HAVE BEEN COLLECTED. AFTER THE CATHETER WAS INTRODUCED INTO THE LEFT ATRIUM, THE SHEATH FILTER HAD TO BE RESET MANUALLY SINCE WAS OUT OF THE SHEATH ON FLUOROSCOPY, BUT NOT INVISIBLE. THERE WERE NO CONSEQUENCES TO THE PATIENT, HOWEVER THE PROCEDURE TOOK LONGER THAN NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891228 ↗
• MalfunctionFeb 4, 2022Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CATHETER WOULD NOT DISPLAY AND THE PROCEDURE WAS CANCELLED AS A RESULT. THE FIRST CATHETER WAS EXCHANGED FOR A SECOND ONE, BUT THE ISSUE REMAINED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451030 ↗
• MalfunctionJan 19, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE, A CLINICALLY SIGNIFICANT DELAY OCCURRED. INITIALLY THE GEOMETRY WAS TOO LARGE SO THAT DURING THE ABLATION, WITHOUT A CONTACT PRESSURE MEASURE, IT WAS NOT CLEAR WHEN THE PHYSICIAN WAS ON THE WALL OF THE HEART OR NOT WITH THE CATHETER. DUE TO SUCH, A CLINICALLY SIGNIFICANT DELAY OCCURRED. DESPITE THE ISSUE, THE PROCEDURE WAS STILL ABLE TO BE COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13288744 ↗
• MalfunctionJan 19, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE, A CLINICALLY SIGNIFICANT DELAY OCCURRED. INITIALLY THE GEOMETRY WAS TOO LARGE SO THAT DURING THE ABLATION, WITHOUT A CONTACT PRESSURE MEASURE, IT WAS NOT CLEAR WHEN THE PHYSICIAN WAS ON THE WALL OF THE HEART OR NOT WITH THE CATHETER. THE LESION WAS PLACED BY THE SYSTEM FAR OUTSIDE THE GEOMETRY AND THIS RESULTED IN A CLINICALLY SIGNIFICANT DELAY. DESPITE THE ISSUE, THE PROCEDURE WAS STILL ABLE TO BE COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13288632 ↗