MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M004RC64S0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Premarket / 510(k) # k143481, k192360, k220796.
Event or Problem Description
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 elevation occurred.The patient had reported discomfort around the time of brockenbrough administration and was treated with primperan, this discomfort had also been present prior to admission.The left atrial appendage potential on opal mapping system (opal) was noisy, and after reviewing fluoroscopy and laboratory times, it was determined that air was likely already present during the mapping phase.The procedure was cancelled.The devices have been received at boston scientifics post market laboratory where it is awaiting analysis.
Additional Manufacturer Narrative
Premarket / 510(k) # k143481, k192360, k220796.Upon receipt at our post market quality assurance laboratory.Visual inspection the device does not have visual defects.Functional test revealed that the catheter functional mechanism worked properly.No abnormal resistance was felt when actuating the device.The continuity test was performed, no electrical problems were detected.Based on the product analysis the reported complaint of " no known device problem" was unable to confirmed.
Event or Problem Description
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 elevation occurred.The patient had reported discomfort around the time of brockenbrough administration and was treated with primperan, this discomfort had also been present prior to admission.The left atrial appendage potential on opal mapping system (opal) was noisy, and after reviewing fluoroscopy and laboratory times, it was determined that air was likely already present during the mapping phase.The procedure was cancelled.The devices have been received at boston scientifics post market laboratory where it is awaiting analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory.Visual inspection the device does not have visual defects.Functional test revealed that the catheter functional mechanism worked properly.No abnormal resistance was felt when actuating the device.The continuity test was performed, no electrical problems were detected.Based on the product analysis the reported complaint of " no known device problem" was unable to confirmed.
Event or Problem Description
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 elevation occurred.The patient had reported discomfort around the time of brockenbrough administration and was treated with primperan, this discomfort had also been present prior to admission.The left atrial appendage potential on opal mapping system (opal) was noisy, and after reviewing fluoroscopy and laboratory times, it was determined that air was likely already present during the mapping phase.The procedure was cancelled.The devices have been received at boston scientifics post market laboratory where it is awaiting analysis.Continuous flushing was not interrupted or stopped during the procedure.Images showing the presence of air are not available due to patient privacy.No sounds were heard that would suggest air being drawn into the sheath or catheter.St elevation was observed in the chest leads, and a pr procedure ecg is not available for comparison due to privacy restrictions.The cause of the st elevation is unknown.The procedure was performed under local anesthesia, and the patient was breathing normally without signs of apnea or deep breathing issues.

• Brand Name: INTELLAMAP ORION
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23728519
• Report Number: 2124215-2025-89236
• Device Sequence Number: 21386486
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968(17)260522(10)35325976
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2026
• Device Model Number: M004RC64S0
• Device Catalogue Number: M004RC64S0
• Device Lot Number: 0035325976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 02/17/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/23/2026; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown