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 Code	Cardiac Tamponade (2226)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
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.

• 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 ; +1(651)440-0979
• MDR Report Key: 25798141
• Report Number: 2124215-2026-37385
• Device Sequence Number: 5816856
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/08/2026

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: 0038912123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 03/24/2026
• 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