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	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
G4: k192360, k220796.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.

• 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; la aurora - heredia ; CS
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50612595
• Report Number: 2124215-2026-47294
• Device Sequence Number: 16110749
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/29/2026
• 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: Required Intervention
• Patient Sex: Unknown