EnSite™ ENSITE-R-AMP-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 05415067034748), received between Mar 2, 2022 and Sep 25, 2026 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (20 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Installation-Related Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903368 ↗
• MalfunctionApr 16, 2026Signal Artifact/Noise

  DURING A TYPICAL AFL PROCEDURE, THERE WAS A PROCEDURAL DELAY. IT WAS NOTED THAT ALL OF THE ELECTRODES ON THE TACTIFLEX CATHETER HAD NOISE ON THEM, AND THE CATHETER APPEARED DISTORTED ON THE GUI. TROUBLESHOOTING INCLUDED REBOOTING, REPLACING THE TACTIFLEX CATHETER, REPLACING THE RF CABLES, REPLACING THE AMPERECONNECT CABLE, REPLACING THE AMPERE, AND REPLACING THE TACTISYS, BUT THE ISSUE PERSISTED. THE AMPLIFIER WAS REPLACED, AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899061 ↗
• MalfunctionFeb 6, 2026Communication or Transmission Problem; Failure of Device to Self-Test

  DURING A PFA PROCEDURE, THERE WAS A DELAY DUE TO A COMMUNICATION AND SELF-TEST ISSUE WITH THE AMPLIFIER AND A FREEZING ISSUE WITH THE DISPLAY WORKSTATION. THE AMPLIFIER DISCONNECTED AND DISPLAYED AN AMBER LIGHT. THERE WERE ABOUT 10 REBOOTS OF THE AMPLIFIER AND 2-3 REBOOTS OF THE DISPLAY WORKSTATION WHILE THE PATIENT WAS ON THE TABLE WITH CORRECT BOOT UP SEQUENCE BEFORE THE CASE COULD BE STARTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275398 ↗
• MalfunctionFeb 6, 2026Communication or Transmission Problem; Failure of Device to Self-Test

  DURING A PFA PROCEDURE, THERE WAS A DELAY DUE TO A COMMUNICATION AND SELF-TEST ISSUE WITH THE AMPLIFIER AND A FREEZING ISSUE WITH THE DISPLAY WORKSTATION. THE AMPLIFIER DISCONNECTED AND DISPLAYED AN AMBER LIGHT. THERE WERE ABOUT 10 REBOOTS OF THE AMPLIFIER AND 2-3 REBOOTS OF THE DISPLAY WORKSTATION WHILE THE PATIENT WAS ON THE TABLE WITH CORRECT BOOT UP SEQUENCE BEFORE THE CASE COULD BE STARTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275393 ↗
• MalfunctionFeb 6, 2026Communication or Transmission Problem; Failure of Device to Self-Test

  DURING A PFA PROCEDURE, THERE WAS A DELAY DUE TO A COMMUNICATION AND SELF-TEST ISSUE WITH THE AMPLIFIER AND A FREEZING ISSUE WITH THE DISPLAY WORKSTATION. THE AMPLIFIER DISCONNECTED AND DISPLAYED AN AMBER LIGHT. THERE WERE ABOUT 10 REBOOTS OF THE AMPLIFIER AND 2-3 REBOOTS OF THE DISPLAY WORKSTATION WHILE THE PATIENT WAS ON THE TABLE WITH CORRECT BOOT UP SEQUENCE BEFORE THE CASE COULD BE STARTED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275382 ↗
• MalfunctionFeb 6, 2026Communication or Transmission Problem; Failure of Device to Self-Test

  DURING A PFA PROCEDURE, THERE WAS A DELAY DUE TO A COMMUNICATION AND SELF-TEST ISSUE WITH THE AMPLIFIER AND A FREEZING ISSUE WITH THE DISPLAY WORKSTATION. THE AMPLIFIER DISCONNECTED MID APPLICATION OF PFA. THE AMPLIFIER DISPLAYED AN AMBER LIGHT. THE SYSTEM WAS REBOOTED WITH EVERYTHING DISCONNECTED. THE CATHETER WOULD THEN NOT VISUALIZE ON ENSITE AND FROZE REQUIRING LOGGING OUT OF THE SYSTEM. THERE WAS AN INTERNAL "RECONNECT TO PFA GENERATOR" WHEN THE VOLT ICON WAS STILL GREEN AND "RECONNECT TO SE SYSTEM" ERROR. THE CURRENT PFA GENERATOR OPTIONS WERE GREYED OUT AND DESPITE RESTARTING THE CURRENT PFA GENERATOR THERE WAS NO RESOLUTION. THE CASE WAS EXITED AND RELOADED, BUT IT WAS NOT POSSIBLE TO RESUME THE CASE. THE PROCEDURE WAS COMPLETED WITHOUT ENSITE USING X-RAY AND WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275380 ↗
• MalfunctionJan 14, 2026Communication or Transmission Problem

  AT THE START OF A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AFTER BEGINNING PATIENT PREPARATION, THERE WAS A COMMUNICATION ISSUE WITH THE ENSITE X AMPLIFIER RESULTING IN CANCELLATION OF THE PROCEDURE. THE STATUS LIGHT OF THE ENSITE X AMPLIFIER WAS FLASHING GREEN. TROUBLESHOOTING INCLUDED REPLACING THE FIBER OPTIC CABLE, RESEATING THE SMALL FORM PLUGGABLE MODULE, AND SWAPPING THE SMALL FORM PLUGGABLE MODULE BETWEEN THE DISPLAY WORKSTATION AND THE ENSITE X AMPLIFIER, BUT THE ISSUE STILL PERSISTED. IT WAS THEN DECIDED TO STOP THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077139 ↗
• MalfunctionJan 13, 2026Communication or Transmission Problem

  DURING A PULMONARY VEIN ISOLATION AND CAVOTRICUSPID ISTHMUS PROCEDURE, THE CAVOTRICUSPID ISTHMUS PORTION OF THE PROCEDURE WAS ABORTED DUE TO AN ENSITE X AMPLIFIER COMMUNICATION ISSUE. WHEN THE CATHETER WAS CONNECTED, A RED SIGNAL WAS NOTED ON THE GUI AROUND THE AMPERE CONNECT PORT OF THE AMPLIFIER AND THE RF SIGNAL WOULD NOT APPEAR. NO PHYSICAL DAMAGE WAS NOTED. THE AMPLIFIER WAS REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055065 ↗
• MalfunctionJan 6, 2026Communication or Transmission Problem

  DURING AN AF/AFL PROCEDURE, THE CASE WAS ABANDONED BEFORE SUCCESSFULLY COMPLETING A CTI ATRIAL FLUTTER LINE. THE PROCEDURE STARTED WITH A PVI. AFTER THE PVI, THE PHYSICIAN WENT INTO THE RIGHT ATRIUM TO DO A CTI ATRIAL FLUTTER LINE, WHERE IT WAS NOTED THAT THE TACTIFLEX FJ WOULD NOT DISPLAY EGMS ON ENSITE X. THE CONNECTIONS WERE CHECKED AND RECONNECTED, THE CASE WAS EXITED AND REENTERED, A NEW CASE WAS STARTED, AND THE SYSTEM WAS POWER CYCLED WITH NO RESOLUTION. THE TACTIFLEX FJ WAS REPLACED WITH ANOTHER FROM THE SAME LOT, BUT THE ISSUE PERSISTED. POST-CASE, DIFFERENT TACTISYS QUARTZ SYSTEMS WERE USED, AND A DIFFERENT AMPERE CONNECT CABLE WAS TRIED WITH NO RESOLUTION. THERE WAS NO ADVERSE PATIENT CONSEQUENCES AND THE CASE ENDED. TECH SERVICES DECIDED IT WOULD BE BEST TO CHANGE THE ENSITE X AMPLIFIER DUE TO POTENTIALLY FAULTY AMPERE CONNECT PORT ON THE FRONT OF THE AMPLIFIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974449 ↗
• MalfunctionDec 30, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THIS REPORT INCLUDES AN UPDATED DEVICE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922058 ↗
• MalfunctionOct 27, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE LEFT SIDED PVC PROCEDURE, COMMUNICATION ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. IT WAS NOTED THAT THE CATHETERS NO LONGER DISPLAYED IN HIGH CONFIDENCE. THE FULL SYSTEM WAS RESTARTED TWICE AND THE TACTIFLEX CATHETER WAS REPLACED WITH NO RESOLUTION. SWITCHING TO NAVX MODE DID NOT SOLVE THE ISSUE EITHER SO THE PROCEDURE WAS ABORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PROCEDURE HAS BEEN RESCHEDULED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393650 ↗
• MalfunctionSep 17, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE AMPLIFIER RESULTING IN A CLINICALLY SIGNIFICANT DELAY. WHILE MAPPING, THERE WERE NO ISSUES. HOWEVER, WHEN ABLATION BEGAN, THE CATHETER MADE INSTANTANEOUS JUMPS INTO THE ATRIUM. THE RIGHT VEINS WERE ABLATED FIRST WITH SOME DIFFICULTY. THE LEFT VEINS COULD NOT BE ABLATED BECAUSE IT WAS TOO DIFFICULT TO VISUALIZE. AFTER THAT, THE HD GRID X CATHETER EXTENDED A LOT ON THE SCREEN. A BASELINE RESET WAS PERFORMED, AND THE ENTIRE MAP AND ABLATION POINTS WERE LOST. DURING THE SECOND RESPIRATORY COMPENSATION, THERE WAS GOOD STABILITY WITH THE CATHETER, AND THE ISSUE HAD RESOLVED. THE TROUBLESHOOTING AND RESTARTS TOOK 30 MINUTES AND WERE BELIEVED TO BE CLINICALLY SIGNIFICANT BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070012 ↗
• MalfunctionAug 20, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  THE AMPLIFIER DID NOT PASS THE SELF-TEST WHICH CAUSED A DELAY IN PROCEDURE. AT THE START OF THE CASE, AFTER PATCHING THE PATIENT, AN ERROR WAS NOTED STATING: "AMPLIFIER HARDWARE ERROR DETECTED" AND "UNABLE TO DETECT MAGNETIC FIELD" AND THE AMPLIFIER WENT TO FLASHING ORANGE. MULTIPLE REBOOTS OF THE AMPLIFIER AND DWS WERE PERFORMED, REBOOTS WITH CABLES DISCONNECTED, AND A REBOOT WITH ONLY THE POWER CABLE CONNECTED, HOWEVER, THE AMPLIFIER STILL BOOTED TO A FLASHING ORANGE LIGHT. ANOTHER AMPLIFIER WAS RETRIEVED FROM ANOTHER HOSPITAL (30 MINUTES) WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849120 ↗
• MalfunctionAug 14, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A FLASHING AMBER LIGHT OCCURRED AND THE CASE WAS CANCELLED. MULTIPLE DIFFERENT REBOOT SEQUENCES WERE DONE AND A SOLID GREEN LIGHT WOULD NOT RETURN. THE LIGHT ON THE AMP WOULD ALSO SWITCH TO SOLID ORANGE AS WELL UPON REBOOT. THE CASE WAS CANCELLED AND THE PATIENT WILL MOST LIKELY BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805790 ↗
• MalfunctionJun 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, A COMMUNICATION ISSUE OCCURRED CAUSING A PROCEDURE DELAY. MAPPING WAS COMPLETED AND THE ABLATION CATHETER WAS INSERTED. WHEN CONNECTING THE ABLATION CATHETER, SIGNALS WERE VISIBLE, BUT THERE WAS NO LOCATION IN NAVX OR VOXEL MODE. THE CATHETER GUI HAD THE AMPERE AND SE PORTS AS RED. THE SITE VERIFIED THE POPULATED CATHETER WAS FULLY DEFINED BUT WERE STILL UNABLE TO SELECT ROVING. THE CATHETER WAS DISCONNECTED AND RECONNECTED (DELETING FROM THE CATHETER LIST). HOVERING OVER QUALITY GUMBALLS SHOWED CATHETER IMPEDANCE ERRORS. THE TACTISYS, AMPERE, TACTIFLEX RF CABLE AND AMPERE CONNECT CABLE WERE EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. THE SYSTEM WAS REBOOTED MULTIPLE TIMES AND A NEW CASE WAS STARTED, BUT THE ISSUE PERSISTED. THE AMPLIFIER WAS THEN EXCHANGED WHICH RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329671 ↗
• MalfunctionMay 30, 2025Communication or Transmission Problem; Impedance Problem; Communication or Transmission Problem; Impedance Problem

  DURING ATRIAL FLUTTER PROCEDURE, COMMUNICATION AND IMPEDANCE ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE TACTIFLEX CATHETER COULD NOT BE VISUALIZED. THE CS CATHETER COULD BE VISUALIZED, BUT A CATHETER IMPEDANCE ERROR AND SE PORT ERROR WERE DISPLAYED. THE AMPERE CONNECT, AMPERE, TACTIFLEX CABLE, TACTISYS, AND THE CATHETER WERE ALL EXCHANGED, BUT THE ISSUE PERSISTED. PORT 1 AND 2 WERE ALSO TRIED, BUT DID NOT RESOLVE THE ISSUE. REPLACING THE AMPLIFIER RESOLVED THE ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116433 ↗
• MalfunctionMay 8, 2025Material Twisted/Bent; Material Twisted/Bent

  AFTER THE PATIENT WAS ON THE TABLE FOR AN ATRIAL FIBRILLATION PROCEDURE, A PIN IN THE AMPERE CONNECT PORT OF THE AMPLIFIER WAS BENT RESULTING IN CANCELLATION OF THE PROCEDURE. THE LED ON THE AMPLIFIER WAS RED WHEN IT WAS BOOTED UP AND RESTARTING IT DID NOT RESOLVE THE ISSUE. THE PORTS OF THE AMPLIFIER WERE THEN VISUALLY INSPECTED. IT WAS THEN NOTED THAT A PIN IN AMPERE CONNECT PORT WAS BENT. AS THE ISSUE COULD NOT BE RESOLVED THE PROCEDURE WAS CANCELLED. THE ISSUE HAS SINCE BEEN RESOLVED BY REPLACING THE AMPLIFIER AND THE PROCEDURE WAS RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988495 ↗
• MalfunctionMay 7, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT PROCEDURE, AN OUTPUT ISSUE OCCURRED CAUSING A PROCEDURE DELAY. IT WAS NOT POSSIBLE TO VISUALIZE THE SIGNALS OF THE ABLATION CATHETER ON THE ENSITE X. THE CATHETER WAS UNPLUGGED AND THEN PLUGGED BACK IN ON THE AMPLIFIER SE PORTS SIDE. THE AMPLIFIER WAS RESTARTED, THE STUDY WAS RESTARTED, A NEW STUDY WAS CREATED, NONE OF WHICH RESOLVED THE ISSUE. THE CATHETER CABLE AND CATHETER WERE EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. THE AMPLIFIER CABLE WAS EXCHANGED, AND ALL AMPLIFIER CONNECTION WERE UNPLUGGED AND PLUGGED BACK IN. NONE OF THESE ACTIONS SOLVED THE ISSUE. IT WAS POSSIBLE TO HAVE THE ENDO SIGNALS OF THE ABLATION WHEN RETRIEVING THEM FROM THE FRONT SIDE OF THE AMPERE WITH AN EGM CABLE. THE SIGNALS WERE STILL TRANSMITTED TO THE NON-ABBOTT (GE CARDIOLAB EP) SYSTEM; VISUALIZATION AND COLLECTION IN NAVX MODE ON NON-SE CATHETERS WAS POSSIBLE. THE AMPLIFIER WAS THEN EXCHANGED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT. POST PROCEDURE, THE ISSUE WAS REPRODUCED WHEN SWITCHING BACK TO THE FAULTY AMPLIFIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976085 ↗
• MalfunctionApr 3, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING A LEFT-SIDED ATRIAL FLUTTER PROCEDURE, AN ORANGE LIGHT WAS NOTED ON THE AMPLIFIER AS WELL AS A SOFTWARE ISSUE AND THE PROCEDURE WAS CANCELLED WITH NO PATIENT CONSEQUENCES. THE PROCEDURE WILL BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761046 ↗
• MalfunctionMar 21, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  THERE WAS A BURNING SMELL COMING FROM THE ENSITE X AMPLIFIER. BIOMED HAD OPENED UP THE BACK AND SAW VISIBLE CHARRING ON THE VOLTAGE REGULATOR ON THE BOARD WHERE THE FIELD FRAME CABLE CONNECTS. REPLACEMENT ORDERED AND INSTALLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665952 ↗
• MalfunctionMar 21, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, CATHETER DISTORTION, EGM NOISE, AND RESPIRATION ISSUES OCCURRED CAUSING A DELAY IN PROCEDURE. AFTER 30 MINUTES OF TROUBLESHOOTING AND DOUBLE CHECKING THE POSITION OF THE CATHETER ON FLUOROSCOPY AND ICE, THE CASE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664792 ↗
• MalfunctionJan 29, 2025Signal Artifact/Noise; Failure of Device to Self-Test; Signal Artifact/Noise; Failure of Device to Self-Test

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SIGNAL AND SELF-TEST ISSUES RESULTED IN A PROCEDURAL DELAY. A BURST OF NOISE WAS NOTED ON ALL CATHETERS AND SURFACE ELECTRODES ON THE NON-ABBOTT DEVICE (BARD RECORDING SYSTEM), BUT THERE WAS NO NOISE ON THE ENSITE SIGNALS. TURING OFF THE ENSITE X AMPLIFIER RESOLVED THE ISSUE. IT WAS ALSO NOTED THAT THE NOISE ISSUE DID NOT OCCUR WHEN USING THE NON-ABBOTT DEVICE (CARTO) WAS THE MAPPING SYSTEM. THE ENSITE X AMPLIFIER WAS REBOOTED BUT THE LIGHT REMAINED ORANGE AND WAS NOT ABLE TO CONNECT TO THE DWS AFTER MULTIPLE REBOOTS. TROUBLESHOOTING INCLUDED REPLACING IC BLOCKS TO NON-ABBOTT DEVICE (BARD) AND PINNING, REPLACING THE SURFACELINK, REPLACING THE EP-4, AND RESTARTING THE ENSITE X AMPLIFIER. THE ISSUE IS INTERMITTENT. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264053 ↗
• MalfunctionNov 19, 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 20724961 ↗
• MalfunctionNov 18, 2024Signal Artifact/Noise; Signal Artifact/Noise

  DURING A SUPRAVENTRICULAR TACHYCARDIA/WOLFF PARKINSON WHITE SYNDROME PROCEDURE, SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. WHEN THE CATHETER WAS INSERTED INTO THE PATIENT, IT WAS NOTED THAT NEITHER THE ABLATION CATHETER NOR THE SIGNAL COULD NOT BE SHOWN ON ENSITE X. HOWEVER, ON THE CLARIS SYSTEM, NOISE WAS NOTED ON THE ABLATION DISTAL SIGNAL. THE ABLATION CATHETER AND THE TACTISYS/AMPERE CONNECTOR CABLE WERE BOTH EXCHANGED BUT THE ISSUE PERSISTED. THE AMPLIFIER WAS EXCHANGED WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705592 ↗
• MalfunctionNov 18, 2024Communication or Transmission Problem; Communication or Transmission Problem

  DURING AN ATYPICAL FLUTTER PROCEDURE, THERE WAS A COMMUNICATION ISSUE WITH THE AMPLIFIER RESULTING IN CANCELLATION OF THE PROCEDURE. THE SURFACE LINK WAS EXCHANGED BUT THE ISSUE DID NOT RESOLVE. THE CORONARY SINUS CATHETER WAS ABLE TO BE VISUALIZED, BUT NOT THE ADVISOR HD GRID CATHETER OR THE NON-ABBOTT MAPPING CATHETER. CHANGING THE PORT THE ADVISOR HD GRID CATHETER WAS CONNECTED TO DID NOT RESOLVE THE ISSUE. SOME PORTS WOULD SHOW ONLY SOME ELECTRODES, OTHER PORTS WOULD SHOW NO ELECTRODES, AND VOXELS WERE UNABLE TO BE COLLECTED. A REPLACEMENT AMPLIFIER AND A FIELD TEST WERE REQUESTED TO TEST CURRENT AMPLIFIER. THE CASE WAS ABANDONED AS NEITHER MAPPING CATHETER SHOWED UP PROPERLY TO MAP THE ATYPICAL FLUTTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20703152 ↗