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	Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Ventricular Fibrillation (2130); Pericardial Effusion (3271); Ischemia Stroke (4418); Unspecified Tissue Injury (4559)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.G4: k143481, k192360, k220796; reported here as the premarket / 510(k) # exceeded the character limit for designated field.
Event or Problem Description
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 infarction.After the procedure the physician expressed concern that tissue may have been scraped away within the heart or left atrial appendage when the orion mapping catheter was in use.The patient was admitted to the hospital, and the patient's current condition is unknown.The device is not expected to be returned for analysis due to disposal.

• 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: 24220566
• Report Number: 2124215-2026-05441
• Device Sequence Number: 9366857
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968(17)270411(10)37675194
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/30/2026

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 Model Number: M004RC64S0
• Device Catalogue Number: M004RC64S0
• Device Lot Number: 0037675194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/30/2026
• Date Device Manufactured: 10/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown