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	Pericardial Effusion (3271)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.The facility indicated they disposed of the device and the batch/lot number was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.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 that pericardial effusion was identified, and a pericardial puncture was performed.During the procedure, transseptal puncture was performed using a non-boston scientific needle, the sureflex sheath was advanced into the left atrium.The intellamap orion catheter was then introduced.Catheter maneuvering appeared unusually difficult, so it was withdrawn to check its function; no issues were detected.The orion catheter was reintroduced into the left atrium, and mapping started.Approximately 15 minutes later, an ultrasound check was performed due to earlier complications, revealing a pericardial effusion.The procedure was immediately aborted, and a pericardial puncture was performed.The patients condition subsequently stabilized.The device was disposed by the facility and will not be returned as the device performed as expected during the procedure and there were no reports of any performance concerns.

• 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: 23866210
• Report Number: 2124215-2025-92365
• Device Sequence Number: 4438483
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143481
• 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): 12/22/2025

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: 12/04/2025
• Initial Report FDA Received Date: 12/22/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown