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); Cardiac Perforation (2513)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
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; 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: 50756333
• Report Number: 2124215-2026-48937
• Device Sequence Number: 9395913
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968(17)271014(10)39083861
• 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): 10/01/2026

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: 0039083861
• 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: 08/28/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 04/14/2026
• 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