IntellaMap Orion™ M004RC64S0Recalls & reported problems

Summary

The FDA's MAUDE database contains 356 adverse event reports that list this exact device (DI 08714729841968), received between Dec 19, 2017 and Sep 29, 2026 — classified as 6 deaths, 162 injuries, 188 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (62 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 356 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Remove; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938863 ↗
• InjurySep 14, 2026Unsealed Device Packaging; Packaging Problem

  It was reported that the inner and outer packaging were damaged, compromising the sterility of the Orion catheter.During preparation for a procedure, packaging of an INTELLAMAP ORION Catheter was damaged on the inner and outer parts of the packaging, compromising the sterility of the device. It was reportedly damaged during transport. The procedure was completed using another device of the same model. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757043 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that cardiac tamponade, requiring unexpected medical intervention and a cancelled procedure occurred.During a radiofrequency (RF) ablation procedure, an IntellaMap Orion Catheter was advanced to the right ventricular outflow tract (RVOT) and deployed, however, the catheter could not be visualized on 3D. The visualization issue was resolved by replacing the umbilical cable; however, during the period when the deployment was not displayed, the catheter had been advanced relatively high within the RVOT. Therefore, the catheter was pushed and pulled to check whether the deployment display would return to normal. The physician suspects that the cardiac perforation may have occurred during this manipulation. The perforation site was the lateral side of the RVOT. Treatment was performed by draining the fluid, and the procedure was cancelled. The patient has recovered.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 50756333 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that pericardial effusion and cardiac tamponade occurred, requiring pericardiocentesis.During a radiofrequency atrial fibrillation ablation procedure, an Intellamap Orion Catheter and a StablePoint Catheter were used. The procedure lasted approximately 1 hour and 30 minutes. Immediately following the procedure, the physician conducted a routine echocardiogram and discovered a pericardial effusion that caused cardiac tamponade. The physician performed a pericardiocentesis in order to drain the effusion, and the effusion was resolved. The patient is stable and there was no further complication. The physician was uncertain if the procedure caused the effusion or if it was pre-existing.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50612595 ↗
• MalfunctionAug 24, 2026Difficult to Remove; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416032 ↗
• MalfunctionAug 20, 2026Difficult to Remove; Deformation Due to Compressive Stress

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351107 ↗
• MalfunctionAug 20, 2026Difficult to Remove

  It was reported that the catheter became entangled in the mitral valve and chordae tendineae during left ventricular mapping via transseptal approach and could not be disengaged.During a procedure to treat ventricular tachycardia (VT) in a patient with hypertrophic obstructive cardiomyopathy (HOCM), an IntellaMap Orion Catheter was selected for use. During left ventricular mapping via transseptal approach, the catheter became entangled in the mitral valve and chordae tendineae and could not be disengaged. Several attempts to free the catheter by deflating the Orion to its undeployed state and applying tension from multiple directions were unsuccessful. It was eventually resolved by firmly retracting the catheter into the sheath. Another of the same device was used and the procedure was completed successfully without patient complications and the patient's hemodynamics remained stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50335390 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced cardiac tamponade and Hypotension. IntellaMap Orion Catheter was selected for use. Once the procedure was completed successfully, the patient blood pressure dropped and pericardial tamponade was noted on ultrasound. No perforation was noted. After the puncture, the patient blood pressure goes up and the patient was stable. The patient was hospitalized due to complication. As per the physician, the device or procedure did not contributed the complications.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 50278463 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a Heart Block and was implanted with a permanent pacemaker.During an atypical atrial flutter, an IntellaMap Orion mapping catheter and FARAWAVE catheter were selected for use. A comprehensive right atrial map was created using the Orion catheter. A HIS cloud was created with the OPAL Mapping System to confirm a safe distance between the planned lesion set and the conduction system. A FARAWAVE NAV 31 mm catheter was then advanced. The ablation strategy targeted the anterior right atrial floor near the tricuspid valve, approximately at the 5 o'clock position. The catheter was deployed in a flower configuration, and six PFA applications were delivered in this region. The tachycardia cycle length progressively slowed with each application. Following the sixth pulse, the atrial tachycardia terminated, however, the patient went into complete heart block. Ventricular conduction was no longer present, and atrial activity continued at a fixed non tachycardic rate. Based on the physician assessment, the device and procedure did not contribute to the adverse event. A non Boston Scientific catheter was advanced to facilitate ventricular pacing. Duri

  Patient problems: Heart Block

  MAUDE report 50263487 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED CARDIAC TAMPONADE OCCURRED. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION IN THE LEFT ATRIUM, AN INTELLAMAP ORION CATHETER WAS FOR USE. TWO HOURS INTO THE PROCEDURE, CARDIAC TAMPONADE OCCURRED WHICH WAS TREATED WITH PERICARDIAL DRAINAGE. FOLLOWING THE PARACENTESIS, THE PATIENT'S BLOOD PRESSURE STABILIZED, NO FURTHER HOSPITALIZATION WAS REQUIRED. THE PATIENT IS RECOVERED.

  Patient problems: Cardiac Tamponade

  MAUDE report 25798141 ↗
• MalfunctionFeb 26, 2026Material Perforation; Difficult to Advance

  IT WAS REPORTED THAT AN INSULATION DAMAGE WAS OBSERVED NEAR THE PROXIMAL PART OF THE CATHETER. DURING A PROCEDURE, AN INTELLAMAP ORION CATHETER WAS USED. WHEN REINSERTING THE DEVICE FOR POST-MAPPING AFTER PULSED FIELD ABLATION (PFA), THE INSERTER WAS ADVANCED; HOWEVER, AN INSULATION DAMAGE WAS OBSERVED NEAR THE PROXIMAL PART OF THE CATHETER, AND THE CATHETER COULD NOT BE INSERTED INTO THE INSERTER. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICE HAS BEEN RECEIVED AND ANALYZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464332 ↗
• MalfunctionFeb 26, 2026Difficult to Remove; Mechanics Altered

  IT WAS REPORTED THAT THE ORION CATHETER WAS LOOPED WITHIN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AND BECAME DIFFICULT TO MOVE. DURING AN ABLATION PROCEDURE TO TREAT PREMATURE VENTRICULAR COMPLEX (PVC), AN INTELLAMAP ORION CATHETER WAS USED. THE ORION CATHETER WAS LOOPED WITHIN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AND BECAME DIFFICULT TO MOVE. THE DEVICE WAS EVENTUALLY REMOVED, AND A "WEIRD CURVE" WAS OBSERVED ON THE CATHETER. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 26, 2026. THERE WAS NO CATHETER ENTRAPMENT; HOWEVER, THERE WAS DIFFICULTY IN PULLING BACK THE CATHETER INTO THE AORTA, AND A "TIGHT CURVE" WAS OBSERVED AS IT WAS RETROFLEXED TO CROSS THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457290 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC TAMPONADE. AFTER AN ABLATION PROCEDURE USING AN INTELLAMAP ORION CATHETER THE PATIENT EXPERIENCED CARDIAC TAMPONADE SHORTLY AFTER RETURNING TO THE HOSPITAL WARD. THE COMPLICATION WENT UNNOTICED ON THE DAY OF THE PROCEDURE AS THE PATIENT'S BLOOD PRESSURE REMAINED STABLE, BUT IT WAS OBSERVED ON ECHOCARDIOGRAM THE FOLLOWING DAY. THE PATIENT HAD A THORACOTOMY PERFORMED SIX DAYS AFTER THE PROCEDURE. THE TAMPONADE LIKELY OCCURRED AROUND THE LEFT INFERIOR (LI) OF THE LEFT ATRIUM (LA). THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO DISPOSAL.

  Patient problems: Cardiac Tamponade

  MAUDE report 24457250 ↗
• MalfunctionFeb 26, 2026Restricted Flow rate; Nonstandard Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE COATING ON THE CATHETER SHAFT WAS TWISTED. CONSEQUENTLY, WHEN THE CATHETER WAS INSERTED INTO THE AGILIS INTRODUCER SHEATH, THE TWISTED COATING APPEARED TO CAUSE A BLOCKAGE, AND FLUSHING WAS UNABLE TO BE PERFORMED. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT ATRIAL FIBRILLATION, AN INTELLAMAP ORION CATHETER WAS USED. IT WAS NOTED THAT THE COATING ON THE CATHETER SHAFT WAS TWISTED. CONSEQUENTLY, WHEN THE CATHETER WAS INSERTED INTO THE AGILIS INTRODUCER SHEATH, THE TWISTED COATING APPEARED TO CAUSE A BLOCKAGE, AND FLUSHING WAS UNABLE TO BE PERFORMED. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE HAS BEEN RECEIVED, PENDING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456320 ↗
• MalfunctionFeb 23, 2026Material Perforation

  IT WAS REPORTED THAT A MATERIAL TEAR OCCURRED. A PULSE FIELD ABLATION (PFA) PROCEDURE FOR PULMONARY VEIN ISOLATION WAS PERFORMED USING A FARAWAVE CATHETER AND INTELLAMAP ORION CATHETER. THE INTELLAMAP ORION CATHETER WAS USED TO ACQUIRE PRE AND POST ABLATION MAPS OF THE LEFT ATRIUM. PRE MAPPING OF THE RIGHT ATRIUM NEAR THE SUPERIOR VENA CAVA WAS COMPLETED AND ABLATION WAS PERFORMED. DURING POST MAPPING OF THE RIGHT ATRIUM THE COATING OF THE INTELLAMAP ORION CATHETER AT THE FLEXION POINT WAS FOUND TO BE TORN. THE INTELLAMAP ORION CATHETER WAS REPLACED WITH A NEW INTELLAMAP ORION CATHETER AND THE PROCEDURE SUCCESSFULLY CONCLUDED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415305 ↗
• MalfunctionFeb 17, 2026Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WAS DIFFICULTY IN PULLING BACK THE CATHETER INTO THE SHEATH, AND THE CATHETER SHAFT WAS SLIGHTLY BENT. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION, AN INTELLAMAP ORION CATHETER WAS USED. PRE-MAPPING OF THE LEFT ATRIUM WAS PERFORMED AS USUAL; HOWEVER, THERE WAS DIFFICULTY IN PULLING BACK THE CATHETER INTO THE SHEATH. UPON REMOVAL OF THE CATHETER, IT WAS OBSERVED THAT THE CATHETER SHAFT WAS SLIGHTLY BENT. THE SHEATH USED WAS 8.5F MODEL, AND NO PROBLEMS WERE NOTED WITH THE SHEATH. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370079 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERICARDIAL EFFUSION DEVELOPED AFTER THE TRANSSEPTAL PUNCTURE. AN INTELLAMAP ORION CATHETER WAS USED DURING THE ATRIAL FIBRILLATION PROCEDURE. AFTER THE TRANSSEPTAL PUNCTURE, A PERICARDIAL EFFUSION WAS NOTED. THE PHYSICIAN BELIEVED THAT THE EFFUSION OCCURRED THE SECOND TIME THE ORION CATHETER WAS TAKEN OUT OF THE LEFT ATRIUM. THE SEQUENCE WAS AS FOLLOWS: THE LEFT ATRIUM WAS MAPPED WITH THE ORION CATHETER, FOLLOWED BY ABLATION WITH THE FARAWAVE CATHETER. THE TEAM THEN ATTEMPTED TO INDUCE AN ARRHYTHMIA, EXCHANGED THE FARAWAVE CATHETER FOR THE ORION CATHETER TO POTENTIALLY MAP A TACHYCARDIA, AND FINALLY EXCHANGED THE ORION CATHETER AGAIN FOR THE FARAWAVE CATHETER. THE EFFUSION WAS DISCOVERED AFTER THE ABLATIONS HAD BEEN PERFORMED AND A PUNCTURE IN THE LEFT ATRIUM WAS IDENTIFIED. PERICARDIAL DRAINAGE WAS PERFORMED AND THE PATIENT UNDERWENT A SURGICAL LEFT ATRIAL APPENDAGE LIGATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER SURGERY AND IS EXPECTED TO MAKE A FULL RECOVERY. NO DEVICE ISSUES WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS, IT WAS DISPOSED.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 24362546 ↗
• MalfunctionFeb 8, 2026Difficult to Remove; Material Perforation

  IT WAS REPORTED THAT THE INSULATION NEAR THE PROXIMAL PART OF THE BASKET WAS LIFTED, RESULTING IN A VISIBLE GAP. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION PERFORMED VIA THE RIGHT INGUINAL PUNCTURE, AN INTELLAMAP ORION CATHETER WAS USED. AFTER MAPPING THE LEFT ATRIUM AND PULLING BACK INTO THE RIGHT ATRIUM, RESISTANCE WAS FELT WHILE RETRACTING THE ORION INTO THE SHEATH. UPON REMOVAL AND INSPECTION, IT WAS NOTED THAT THE INSULATION NEAR THE PROXIMAL PART OF THE BASKET WAS LIFTED, RESULTING IN A VISIBLE GAP. ANOTHER OF THE SAME DEVICE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICE HAS BEEN RECEIVED, PENDING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288705 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CEREBRAL INFARCTION. VENTRICULAR TACHYCARDIA (VT), VENTRICULAR FIBRILLATION (VF), ST SEGMENT ELEVATION, PERICARDIAL EFFUSION, AND TISSUE DAMAGE. DURING A PULSE FIELD ABLATION (PFA) PROCEDURE TO TREAT PERSISTENT ATRIAL FIBRILLATION AN INTELLAMAP ORION CATHETER WAS USED. PULMONARY VEIN ISOLATION (PVI) AND POSTERIOR WALL ISOLATION TOOK PLACE WITH THE CATHETER. DURING THE FINAL STAGE OF THE POSTERIOR WALL ISOLATION AN ST SEGMENT ELEVATION WAS OBSERVED ON THE ELECTROCARDIOGRAM (ECG) AFTER DELIVERING A PULSE NEAR THE BOTTOM OF THE RIGHT INFERIOR PULMONARY VEIN (RIPV). VT (VF) DEVELOPED AFTER THE ST ELEVATION. EXTERNAL DEFIBRILLATION WAS PERFORMED WHICH RESTORED SINUS RHYTHM. ADMINISTRATION OF MEDICATION AND CORONARY ANGIOGRAPHY (CAG) FOLLOWED THE DEFIBRILLATION. THERE APPEARED TO BE NO SIGNIFICANT OCCLUSIONS OR SPASMS NOTED IN THE CORONARY ARTERIES. A PERICARDIAL EFFUSION WAS DISCOVERED VIA ECHOCARDIOGRAPHY FROM THE SURFACE OF THE BODY. THE ECG CHANGES GRADUALLY RETURNED TO NORMAL, AND THE ST SEGMENT ELEVATION STABILIZED. THE PROCEDURE WAS COMPLETED, THEN THE PATIENT WAS TAKEN FOR A COMPUTED TOMOGRAPHY (CT) SCAN WHICH REVEALED A CEREBRAL INFAR

  Patient problems: Arrhythmia; Ischemia Stroke; Non specific EKG/ECG Changes; Pericardial Effusion; Unspecified Tissue Injury; Ventricular Fibrillation

  MAUDE report 24220566 ↗
• MalfunctionDec 26, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE CATHETER COULD NOT BE FULLY UNDEPLOYED FOR RETRIEVAL. DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION, AN INTELLAMAP ORION CATHETER WAS USED. AFTER INSERTION INTO THE LEFT ATRIUM, THE CATHETER WAS FULLY DEPLOYED TO GATHER THE CHAMBER GEOMETRY. HOWEVER, IT COULD NOT BE FULLY UNDEPLOYED FOR RETRIEVAL. MULTIPLE ATTEMPTS TO USE THE HANDLE MECHANISM TO UNDEPLOY THE CATHETER WERE UNSUCCESSFUL. CONSEQUENTLY, THE CATHETER WAS FORCED INTO THE TRANSSEPTAL SHEATH AND WAS EVENTUALLY REMOVED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898416 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S BLOOD PRESSURE DROPPED, AND PERICARDIAL EFFUSION WAS CONFIRMED. DURING A PROCEDURE TO TREAT ATRIAL FIBRILLATION, AN INTELLAMAP ORION CATHETER WAS USED. WHILE MAPPING, THE CATHETER WAS OFTEN SEEN IN THE LEFT ATRIAL APPENDAGE (LAA). AFTER 20 MINUTES OF ABLATION AND MAPPING, THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY, AND A PERICARDIAL EFFUSION WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED, SUCCESSFULLY RESOLVING THE ISSUE. THE PATIENT LEFT THE OPERATING ROOM ALERT AND IN GOOD CONDITION. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS ADMITTED FOR FULL RECOVERY. THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 23884922 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERICARDIAL EFFUSION WAS IDENTIFIED, AND A PERICARDIAL PUNCTURE WAS PERFORMED. DURING THE PROCEDURE, TRANSSEPTAL PUNCTURE WAS PERFORMED USING A NON-BOSTON SCIENTIFIC NEEDLE, THE SUREFLEX SHEATH WAS ADVANCED INTO THE LEFT ATRIUM. THE INTELLAMAP ORION CATHETER WAS THEN INTRODUCED. CATHETER MANEUVERING APPEARED UNUSUALLY DIFFICULT, SO IT WAS WITHDRAWN TO CHECK ITS FUNCTION; NO ISSUES WERE DETECTED. THE ORION CATHETER WAS REINTRODUCED INTO THE LEFT ATRIUM, AND MAPPING STARTED. APPROXIMATELY 15 MINUTES LATER, AN ULTRASOUND CHECK WAS PERFORMED DUE TO EARLIER COMPLICATIONS, REVEALING A PERICARDIAL EFFUSION. THE PROCEDURE WAS IMMEDIATELY ABORTED, AND A PERICARDIAL PUNCTURE WAS PERFORMED. THE PATIENTS CONDITION SUBSEQUENTLY STABILIZED. THE DEVICE WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS.

  Patient problems: Pericardial Effusion

  MAUDE report 23866210 ↗
• MalfunctionDec 19, 2025Fluid/Blood Leak; Device Sensing Problem; Fluid/Blood Leak; Device Sensing Problem

  IT WAS NOTED THAT LIQUID ENTERED THE TAIL END OF THE DEVICE AND COULD NOT BE DISPLAYED PROPERLY ON THE SYSTEM. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, AN INTELLAMAP ORION CATHETER WAS USED IN THE PULMONARY VEINS. IT WAS NOTED THAT LIQUID ENTERED THE TAIL END OF THE DEVICE AND COULD NOT BE DISPLAYED PROPERLY ON THE SYSTEM. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850552 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, A FARADRIVE STEERABLE SHEATH CLEAR AND AN INTELLAMAP ORION CATHETER WERE SELECTED FOR USE. AFTER PERFORMING PRE MAPPING WITH SUPERIOR LEFT POSITIONING IN THE ORION CATHETER, SWITCHING TO THE FARADRIVE SHEATH REVEALED AN AIR LIKE WHITE HAZE IN THE LEFT ATRIAL APPENDAGE UNDER FLUOROSCOPY AT 14:18. THE AIR LIKE WHITE HAZE WAS OBSERVED BEFORE INSERTING FARADRIVE. ASPIRATION WAS ATTEMPTED AFTER INSERTING THE FARADRIVE SHEATH, BUT LITTLE AIR WAS REMOVED. APPROXIMATELY FIVE MINUTES LATER, ST SEGMENT ELEVATION (ST ELEVATION) WAS OBSERVED ON FLUOROSCOPY. CORONARY ANGIOGRAPHY (CAG) WAS PERFORMED, BUT THE AREA BEYOND THE RIGHT CORONARY ARTERY (RCA) ORIGIN WAS NOT VISUALIZED, PROMPTING SUCTION. AN ST SEGMENT CHANGE OCCURRED DURING SUCTION, AND THE LEFT CORONARY ARTERY (LCA) WAS SUBSEQUENTLY VISUALIZED. BECAUSE OF THE POSSIBILITY THAT AIR HAD REACHED THE BRAIN, CEREBRAL ANGIOGRAPHY WAS ALSO PERFORMED. ABOUT ONE HOUR AFTER THE ST SEGMENT ELEVATION, ST LEVELS DECREASED. FOLLOWING RECOVERY FROM ANESTHESIA, THE PATIENT REGAINED CONSCIOUSNESS, SHOWING NO SYMPTOMS OTHER THAN DELIRIUM, AND WAS TAKEN FOR COMPUTED TOMOGRAPHY (CT) IMAGING. ABLATION WAS NOT BEING PERFORMED WHEN ST ELEV

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 23728519 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED, AND CARDIAC TAMPONADE WAS SUSPECTED. DRAINAGE WAS SUBSEQUENTLY PERFORMED. AN INTELLAMAP ORION CATHETER WAS SELECTED FOR MAPPING THE LEFT ATRIAL, AND MITRAL ABLATION WAS CARRIED OUT. HOWEVER, THE PATIENT'S BLOOD PRESSURE SUDDENLY DROPPED, AND CARDIAC TAMPONADE WAS SUSPECTED. DRAINAGE WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISPOSED OF BY THE FACILITY.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 23694942 ↗