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	01/30/2026
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) #'s exceeded the character limit for designated field).
Event or Problem Description
It was reported that the patient experienced cardiac tamponade.After an ablation procedure using an intellamap orion catheter the patient experienced cardiac tamponade shortly after returning to the hospital ward.The complication went unnoticed on the day of the procedure as the patient's blood pressure remained stable, but it was observed on echocardiogram the following day.The patient had a thoracotomy performed six days after the procedure.The tamponade likely occurred around the left inferior (li) of the left atrium (la).The current condition of the patient is unknown.The device is not expected to be returned for analysis due to disposal.
Additional Manufacturer Narrative
Investigation summary: based on the available information, although no product has been returned due to disposal, we have determined that the cardiac tamponade is a known inherent risk with use of this product.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: it was indicated the device is unavailable for return; therefore, a technical analysis of the complaint device could not be completed.Labeling review: review of the instructions for use confirmed that cardiac tamponade is addressed as a potential procedural complication when using the intellamap orion high resolution mapping catheter.Additionally, based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.Risk review: a review of the intellamap orion high resolution mapping catheter risk documentation was completed and confirmed that the event of cardiac tamponade was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on the information provided, the reported event of cardiac tamponade is a known inherent risk of the intellamap orion high resolution mapping catheter.As stated by the instructions for use, "potential adverse events related to the mapping, the ablation catheter(s), and/or the interventional procedure include, but are not limited to: cardiac trauma, for example: cardiac tamponade." there were no indications that the device was used outside the bounds of labeled/indicated use or evidence of a product performance related issue.G4: k143481, k192360, k220796 (reported here as the premarket / 510(k) #'s exceeded the character limit for designated field).
Event or Problem Description
It was reported that the patient experienced cardiac tamponade.After an ablation procedure using an intellamap orion catheter the patient experienced cardiac tamponade shortly after returning to the hospital ward.The complication went unnoticed on the day of the procedure as the patient's blood pressure remained stable, but it was observed on echocardiogram the following day.The patient had a thoracotomy performed six days after the procedure.The tamponade likely occurred around the left inferior (li) of the left atrium (la).The current condition of the patient is unknown.The device is not expected to be returned for analysis due to disposal.It was further reported that the patient was discharged from the hospital.

• 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: 24457250
• Report Number: 2124215-2026-10748
• Device Sequence Number: 9968844
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968(17)270522(10)37991971
• 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,Followup
• Report Date (Section B): 03/20/2026

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: 0037991971
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/20/2026
• Date Device Manufactured: 11/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown