EnSite™ ENSITE-AMP-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 05415067034755), received between Sep 22, 2021 and Jul 27, 2026 — classified as 2 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (52 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 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Power Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50006224 ↗
• MalfunctionApr 30, 2026Failure of Device to Self-Test

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE USING RF, THE CORONARY SINUS CATHETER COULD NOT BE VISUALIZED RESULTING IN A DELAY. REBOOTING THE DWS GAVE COMMUNICATION ERRORS BETWEEN THE AMPLIFIER, DWS, AND FIELD FRAME CONNECTION. REBOOTING THE AMPLIFIER AGAIN RESULTED IN A FLASHING AMBER STATUS LIGHT. REBOOTING THE DWS AND AMPLIFIER FOR A 3RD TIME RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049900 ↗
• MalfunctionMar 30, 2026Component Missing; Installation-Related Problem

  THIS REPORT INCLUDES UPDATED DEVICE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716295 ↗
• MalfunctionMar 30, 2026Communication or Transmission Problem

  DURING AN ABLATION PROCEDURE, COMMUNICATION ISSUES WITH THE AMPLIFIER RESULTED IN A PROCEDURAL DELAY. THERE WAS A COMMUNICATION ISSUE WHICH RESULTED IN THE CATHETERS APPEARING DISTORTED AND STRETCHED FLAT. TROUBLESHOOTING INCLUDED EXCHANGING THE SURFACELINK, THE PATCHES, REFERENCE PATCH, CATHETERS, STARTING A NEW STUDY, RESTARTING THE DISPLAY WORKSTATION AND AMPLIFIER, CHANGING OUTLETS AND CABLES, AND ENSURING THAT PATIENT DATA CRITERIA WAS ENTERED CORRECTLY. THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED BY EXCHANGING THE AMPLIFIER. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708977 ↗
• MalfunctionMar 26, 2026Communication or Transmission Problem

  DURING PVC (PF) PROCEDURE, COMMUNICATION ISSUES WITH THE AMPLIFIER RESULTED IN A PROCEDURAL DELAY. THE PROCEDURE WAS STARTED IN ENSITE X VOXEL MODE, AND THE ADVISOR HD GRID X CATHETER WAS RECOGNIZED, AND THE ELECTRIC POTENTIALS WERE DISPLAYED, BUT THE CATHETER WAS NOT DISPLAYED. WHEN SWITCHING TO NAVX MODE, IT WAS DISPLAYED, SO A MAGNETIC SENSOR ISSUE WAS SUSPECTED. THE CABLE WAS REPLACED, THE CATHETER WAS REPLACED, AND THE ENSITE X WAS RESTARTED WITH NO RESOLUTION. SINCE IT WAS CONNECTED TO PORT 8 ON THE ENSITE X AMPLIFIER, THE PORT WAS CHANGED TO PORT 7, AND THE CATHETER WAS DISPLAYED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE ENSITE X AMPLIFIER AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700202 ↗
• MalfunctionMar 7, 2026Communication or Transmission Problem

  DURING A PROCEDURE, THE EQUIPMENT PRESENTED AN ERROR WHEN ATTEMPTING TO COLLECT THE GEOMETRY WITH THE HD GRID CATHETER RESULTING IN CANCELLATION OF THE PROCEDURE. THE SYSTEM WAS RUNNING VERSION 3.1.1 AND ALL LICENSES ARE ENABLED. IT WAS ATTEMPTED TO RESTART THE ENTIRE SYSTEM AND THE CATHETER WAS REPLACED, BUT THE ISSUE PERSISTED. THE DISTORTION GRAPH FOR VOXEL APPEARED NORMAL, AND NO ERROR MESSAGES WERE DISPLAYED. IN THE END, THE PROCEDURE HAD TO BE CANCELED DUE TO THE INABILITY TO USE THE EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541114 ↗
• MalfunctionMar 6, 2026Thermal Decomposition of Device; Failure to Power Up; Power Problem

  DURING DEVICE PREPARATION FOR THE ATRIAL FIBRILLATION PFA PROCEDURE, BEFORE THE PATIENT ENTERED THE ROOM, THE AMPLIFIER WAS UNABLE TO POWER ON. THE SYSTEM WAS REPLACED WITH A NON-ABBOTT SYSTEM (CARTO), AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON INSPECTION OF THE POWER COMPONENTS, BURN-LIKE MARKS WERE OBSERVED ON THE FEMALE AMPLIFIER POWER CONNECTOR PORT, SUGGESTING A POSSIBLE SHORT CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535457 ↗
• MalfunctionMar 2, 2026Communication or Transmission Problem

  DURING THE DEVICE PREPARATION FOR THE RADIOFREQUENCY ATRIAL FIBRILLATION PROCEDURE, THE PROCEDURE WAS CANCELLED DUE TO AN AMPLIFIER ISSUE WITH THE PATIENT PREPARED. AFTER STARTING A NEW CASE ON ENSITE X, IT WAS NOTED THAT THERE WAS AN "AMPLIFIER HARDWARE" ERROR MESSAGE THAT APPEARED ON THE DISPLAY AND THEN "CANNOT DISABLE THE MAGNETIC FIELD" WAS DISPLAYED. THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24492271 ↗
• MalfunctionFeb 5, 2026Power Problem

  DURING AN ATRIAL FLUTTER PROCEDURE, AFTER THE PATIENT WAS PREPPED, IT WAS NOTED THAT THE ENSITE X AMPLIFIER DID NOT START PROPERLY CAUSING A DELAY. IT TOOK 1 HOUR AND 30 MINUTES TO TURN ON THE AMPLIFIER, AND BOOT TO A SOLID GREEN LIGHT. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268895 ↗
• MalfunctionJan 26, 2026Communication or Transmission Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, THERE WERE COMMUNICATION ISSUES WITH THE ADVISOR HD GRID X CATHETER AND THE TACTIFLEX ABLATION CATHETER RESULTING IN A DELAY. IT WAS NOTED THAT THE ADVISOR HD GRID X CATHETER COULD NOT BE VISUALIZED USING PORT 8 AND THAT A MAGNETIC SENSOR ERROR WAS DISPLAYED. THE CABLE WAS EXCHANGED, WITHOUT RESOLUTION. THE CATHETER WAS EXCHANGED, AND CONNECTED INTO PORT 7 WHICH RESOLVED THE ISSUE. HOWEVER, THE TACTIFLEX CATHETER ALSO WAS NOT BEING RECOGNIZED AND DISPLAYED AN ERROR STATING "CATHETER NOT CONNECTED". THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES. DESPITE REPLACING THE CATHETERS RESOLVING THE ISSUE DURING THE PROCEDURE THE ENSITE X AMPLIFIER WAS LATER RETURNED. DURING ANALYSIS, A SENSOR CONTROL UNIT ISSUE WAS CONFIRMED AND BASED ON THIS NEW INFORMATION THIS DEVICE COULD BE ATTRIBUTED TO THE FIELD REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184190 ↗
• MalfunctionJan 13, 2026Communication or Transmission Problem; No Apparent Adverse Event

  DURING A PVI ATRIAL FIBRILLATION (AF) AND CTI ATRIAL FLUTTER PROCEDURE (AFL), COMMUNICATION ISSUES WITH THE AMPLIFIER RESULTED IN THE CANCELLATION OF THE PROCEDURE. IT WAS NOTED THAT THE TACTISYS QUARTZ WAS FLASHING GREEN AND RED ON THE RESET BUTTON. IT WAS SUSPECTED THERE WAS AN ISSUE WITH THE CONNECTION PORT ON THE ENSITE X AMPLIFIER. THE PVI AF PORTION OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING PFA. THE CTI AFL PORTION OF THE PROCEDURE WAS POSTPONED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24058227 ↗
• MalfunctionDec 12, 2025Communication or Transmission Problem; Failure of Device to Self-Test; Communication or Transmission Problem; Failure of Device to Self-Test

  DURING A RF PREMATURE VENTRICULAR CONTRACTION PROCEDURE, CONNECTION BETWEEN THE ENSITE X AMPLIFIER TO THE DISPLAY WORKSTATION COULD NOT BE ESTABLISHED AND THE LIGHT WAS FLASHING GREEN RESULTING IN A DELAY. THE PORTS AND FIBER OPTIC CONNECTIONS WERE CHECKED. RESTARTING THE AMPLIFIER RESULTED IN AN ORANGE BLINKING STATUS LIGHT. THIS TROUBLESHOOTING WAS REATTEMPTED MULTIPLE TIMES WITH NO RESOLVE. THE CONNECTIONS AT THE FRONT OF THE AMPLIFIER WERE DISCONNECTED, THE FIBER OPTIC CABLES WERE EXCHANGED, AND THE DISPLAY WORKSTATION AND AMPLIFIER WERE RESTARTED MULTIPLE TIMES. AFTER MULTIPLE TRIES A CONNECTION WAS ESTABLISHED WITH THE ORIGIN CABLES. APPROXIMATELY 30 MINUTES WAS SPENT TROUBLESHOOTING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790349 ↗
• MalfunctionDec 12, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  AFTER PLACING PATCHES ON THE PATIENT FOR AN ATYPICAL ATRIAL FLUTTER PROCEDURE, THERE WAS A SELF-TEST ISSUE WITH THE AMPLIFIER RESULTING IN CANCELLATION OF THE PROCEDURE. PRIOR TO INSERTION OR VEIN ACCESS, THE SYSTEM SHOWED AN ERROR THAT STATED THERE WAS NO CONNECTION TO THE AMPLIFIER, AND THE AMPLIFIER LED WAS ORANGE. ALL CABLES WERE CHECKED, AND THE FIBER OPTIC CABLE WAS VERIFIED TO BE PLUGGED INTO THE AMPLIFIER AND DISPLAY WORKSTATION PROPERLY. THE AMPLIFIER WAS THEN RESTARTED, BUT THE ERROR MESSAGE PERSISTED. THE DISPLAY WORKSTATION AND AMPLIFIER WERE THEN SHUT DOWN. BOTH WERE RESTARTED AFTER A FEW SECONDS, HOWEVER AFTER BIO-IMPEDANCE VALIDATION FOR THE 3D-PATCHES WAS DONE THE ERROR MESSAGE REOCCURRED AND THE AMPLIFIER CONNECTION WAS AGAIN LOST. THE DEVICES WERE REBOOTED AGAIN AND THE FIBER OPTIC CABLE FROM THE AMPLIFIER TO DISPLAY WORKSTATION WAS SWAPPED BUT THE ISSUE PERSISTED. THE CONNECTION WOULD ONLY LAST A FEW SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786561 ↗
• MalfunctionNov 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A SHEATH FILTER AND COMMUNICATION ISSUES WITH THE ENSITE X SOFTWARE, AMPLIFIER, AND DISPLAY WORKSTATION RESULTING IN A DELAY. THE ENSITE X AMPLIFIER WAS FLASHING RED AND THE CATHETER WAS UNABLE TO BE CONNECTED. IT ALSO KEPT SHOWING THAT THE CATHETER WAS IN THE SHEATH AND NO CATHETER DATA COULD BE DISPLAYED. ADDITIONALLY, DURING THE PROCEDURE THERE WAS A CONTACT FORCE ERROR WITH LOSS OF THE PRESSURE VALUE. DURING THIS THE MAGNETIC POINT WOULD DISCONNECT. AFTER REPLACING THE ENSITE X DISPLAY WORKSTATION THE CONTACT FORCE ISSUE RESOLVED. TROUBLESHOOTING ALSO INCLUDED REPLACING THE CATHETER AND RESTARTING THE ENSITE X DISPLAY WORKSTATION AT LEAST 3 TIMES, BUT THE SHEATH FILTER ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23627066 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, IT WAS NOTED THAT THE TECH WAS "SHOCKED" WHEN THE HD GRID WAS CONNECTED TO THE AMPLIFIER. THE TECH WAS NOT INJURED AND NO INTERVENTION WAS REQUIRED.

  Patient problems: Electric Shock

  MAUDE report 23513188 ↗
• MalfunctionNov 3, 2025Signal Artifact/Noise; Improper or Incorrect Procedure or Method; Communication or Transmission Problem; Failure of Device to Self-Test; Signal Artifact/Noise; Improper or Incorrect Procedure or Method; Communication or Transmission Problem; Failure of Device to Self-Test

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WERE COMMUNICATION, SIGNAL, SELF-TEST, AND USER ISSUES WITH THE AMPLIFIER RESULTING IN A DELAY. WHILE ATTEMPTING TO START A NEW CASE IN A LAB THAT HAS NOT BEEN USED BEFORE, IT WAS REPORTED THAT THE ROOM MAY HAVE POWER DRAW PROBLEMS, AND THE AMPLIFIER BOOTED UP TO A FLASHING AMBER LIGHT AND THERE WAS CATHETER DISTORTION. AFTER MULTIPLE REBOOTS WITH EVERYTHING DISCONNECTED, IT WAS POSSIBLE TO SUSTAIN A SOLID GREEN CONNECTION OF THE AMPLIFIER. AT TIMES IT WOULD BE SOLID GREEN THEN IT WOULD GO BACK TO FLASHING AMBER AFTER PLUGGING IN THE SURFACELINK OR FIELD FRAME GENERATOR. AFTER STARTING THE CASE, THE CATHETERS WOULD PROVIDE SIGNALS BUT WOULD APPEAR RED AND DISTORTED. AFTER CHECKING THE PATCHES AND SWAPPING THE SURFACELINK, THE ISSUE WAS NOT RESOLVED. THE SYSTEM WAS REBOOTED APPROXIMATELY 20 TIMES IN NAVX MODE, AND THE CATHETERS COULD BE VISUALIZED. THERE WAS NOTHING CHANGED IN REGARD TO THE PATCHES OR THE CONNECTIONS TO THE RECORDING SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES. DURING TROUBLESHOOTING, IT WAS NOTED THAT THEY WERE USING A IN REGARD TO 3 RECORDING SYSTEM WITH THE RIGHT LEG DRIVE SET TO 4, WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458188 ↗
• MalfunctionOct 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE AMPLIFIER AND A BENT PIN ON THE FIELD FRAME CABLE RESULTING IN CANCELLATION OF THE PROCEDURE. THE FIELD FRAME GENERATOR WAS NOT ABLE TO CONNECT TO THE AMPLIFIER. DESPITE MULTIPLE RESTARTS OF THE AMPLIFIER AND DISPLAY WORKSTATION, AND AFTER VERIFYING ALL CONNECTIONS, IT WAS FOUND THAT ONE OF THE PINS ON THE FIELD FRAME CABLE WAS BROKEN. THE CABLE AND FIELD FRAME WERE EXCHANGED BUT THE ISSUE DID NOT RESOLVE. THE SYSTEM WAS SWITCHED TO NAVX MODE, HOWEVER THE CATHETERS WERE NOT VISIBLE. IT IS ALLEGED THAT THE AMPLIFIER WAS CAUSING THE ISSUE. DUE TO THE ISSUE NOT BEING RESOLVED, THE PROCEDURE WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376251 ↗
• MalfunctionOct 15, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE PVC PROCEDURE, OUTPUT ISSUES WITH THE AMPLIFIER RESULTED IN A DELAY OF PROCEDURE. THE CATHETER WAS NOT DISPLAYING AS EXPECTED ON THE ENSITE X SYSTEM WITH ELECTRODES 2 AND 3 APPEARING DISTORTED. THE EGM ELECTROGRAM WAS NOISY ON THE MAPPING SYSTEM BUT CLEAR ON THE RECORDING SYSTEM. THE CONNECTIONS WERE CHECKED WITH NO RESOLUTION. THE CATHETER WAS REPLACED BUT THE SECOND CATHETER ALSO HAD THE SAME ISSUE. THE CONNECTIONS WERE CHECKED AGAIN, THE YELLOW CABLE FROM THE AMPLIFIER TO THE AMPERE WAS CHANGED, THE CABLE BETWEEN THE TACTISYS AND AMPERE WAS CHANGED, AND THE PORTS WERE CHANGED WITH NO RESOLUTION. THE CATHETER WAS REPLACED AGAIN BUT THE THIRD CATHETER ALSO HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH THE THIRD CATHETER WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. REPLACING THE AMPLIFIER RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303150 ↗
• MalfunctionSep 17, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING AN ATRIAL FLUTTER PROCEDURE, THE ENSITE X AMPLIFIER WAS SHOWING AN ORANGE FLASHING STATUS LIGHT RESULTING IN A DELAY. A POWER CYCLE HAD BEEN DONE; HOWEVER, THE ORANGE FLASHING LIGHT WAS STILL PRESENT. DESPITE POWER CYCLING THE AMPLIFIER AND DISPLAY WORKSTATION 6 TIMES AND REPLACING THE FIBER OPTIC CABLE, THE ISSUE WAS NOT RESOLVED. THE ORIGINAL FIBER OPTIC CABLE WAS USED, AND THE DEVICES WERE POWER CYCLED WITH NO HARDWARE PLUGGED INTO THE FRONT OF THE AMPLIFIER. THE CONNECTION WAS RESUMED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070054 ↗
• MalfunctionSep 5, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. THE ABLATION CATHETER ELECTRODE 3 WAS NOISY AND THE ELECTRODE WAS NOT VISUALIZING PROPERLY ON THE CATHETER. THE AMPERE CONNECT CABLES, AMPERE GENERATOR, TACTISYS AND TACTISYS RF CABLE WERE ALL SWAPPED, BUT THE ISSUE PERSISTED. THE ELECTRODE 3 WAS DISCONNECTED IN THE ENSITE CATHETER SETUP TAB WHICH ALLOWED THE CATHETER TO DISPLAY ON THE SYSTEM PROPERLY, WITHOUT ELECTRODE 3, BUT THE ABLATION PROXIMAL SIGNALS COULD NOT BE USED AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984998 ↗
• MalfunctionJun 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  PRIOR TO A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, WITH THE PATIENT PREPPED, A COMMUNICATION ISSUE OCCURRED AND THE PROCEDURE WAS CANCELLED. THE ENSITE X AMPLIFIER WAS BLINKING ORANGE AND WOULD NOT CONNECT TO THE DWS. THE ISSUE WAS RESOLVED BY DISCONNECTING THE FIELD FRAME AND RESTARTING THE ENTIRE SYSTEM. THE PROCEDURE WAS CANCELLED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345026 ↗
• MalfunctionMay 23, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A NOISE ISSUE OCCURRED RESULTING IN A DELAY. THE CATHETER WAS INSERTED INTO THE RIGHT VENTRICLE AND THE THIRD ELECTRODE DID NOT DISPLAY CORRECTLY ON THE ENSITE MAPPING SYSTEM IN NAVX MODE. ADDITIONALLY, THE EGM SIGNALS WERE NOISY (3-4) ON BOTH THE WORKMATE CLARIS AND ENSITE SYSTEMS. THE CATHETER WAS EXCHANGED FOR ANOTHER OF THE SAME LOT BUT THE ISSUE PERSISTED. THE TACTIFLEX CABLE, AMPERE-TO-ENSITE AMP CABLE, TACTISYS QUARTZ AND AMPERE RF GENERATORS WERE ALL SWITCHED OUT TO TROUBLESHOOT BUT THE ISSUE PERSISTED. IN VOXEL MODE, ELECTRODE 3 WAS NOT VISUALIZED ON ENSITE. THE ELECTRODE WAS THEN HIDDEN ON THE WORKMATE CLARIS AND ENSITE IN ORDER TO MINIMIZE THE DISTRACTION FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. IT WAS THEN CONCLUDED THE ISSUE WAS DUE TO THE ENSITE X AMPLIFIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078569 ↗
• MalfunctionMay 9, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) PROCEDURE, WHEN THE ADVISOR HD GRID CATHETER WAS INSERTED INTO THE PATIENT AND THE CABLE WAS CONNECTED TO PORT 7 OF THE ENSITE X AMPLIFIER, THE ERROR MESSAGE "!" WAS DISPLAYED ON THE AMPLIFIER AND THE CATHETER WAS NOT RECOGNIZED. TROUBLESHOOTING INCLUDED RESTARTING THE AMPLIFIER TWICE, THE DWS ONCE, REPLACING THE CATHETER CABLE, CATHETER, AND SURFACE ELECTRODE KIT, BUT THE ISSUE PERSISTED. THE ISSUE WAS RESOLVED BY CONNECTING THE CATHETER INTO PORT 4 OF THE AMPLIFIER. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996372 ↗
• MalfunctionApr 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PROCEDURE, THERE WAS A "LEFT LEG OR SYSTEM REFERENCE" ERROR RESULTING IN CANCELLATION OF THE PROCEDURE. THE PATCHES WERE REPLACED, AS WELL AS OTHER VARIOUS TROUBLESHOOTING MEASURES, HOWEVER THE ISSUE DID NOT RESOLVE. THE ISSUE WAS ALLEGED TO BE DUE TO THE ENSITE X SURFACELINK. HOWEVER, REPLACING IT DID NOT RESOLVE THE ISSUE AND THE PROCEDURE WAS CANCELLED. AFTER FURTHER TROUBLESHOOTING IT WAS DETERMINED THAT THE AMPLIFIER WAS CAUSING THE ISSUE. THERE WAS NO ALLEGED PERFORMANCE ISSUE WITH THE SURFACELINK OR THE TWO SETS OF PATCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763539 ↗
• MalfunctionMar 20, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING THE ATRIAL FIBRILLATION PROCEDURE, SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. WHEN USING A TACTIFLEX CATHETER, THE EGM SIGNAL COULD NOT BE ACQUIRED, AND THE CATHETER COULD NOT BE VISUALIZED. TROUBLESHOOTING INCLUDED CONFIRMING THE TACTIFLEX 3.1 SOFTWARE WAS INSTALLED, REPLACING THE CATHETER, THE AMPERE CONNECT CABLE, THE TACTISYS, AND THE TACTIFLEX RF CABLE, AS WELL AS USING A DIFFERENT SE PORT. NONE OF THESE MEASURES RESOLVED THE ISSUE. THE ENSITE X SYSTEM WAS REBOOTED, AND DIFFERENT POWER SOURCES FOR THE TACTIFLEX AND AMPERE WERE TRIED WITH NO RESOLUTION. THE AMPLIFIER WAS REPLACED WAS THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652192 ↗