MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M004RC64S0
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter's facility name is (b)(6); reported here as the facility name exceeded character limit for designated field.It was indicated that the device will be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was noted that liquid entered the tail end of the device and could not be displayed properly on the system.During an ablation procedure to treat atrial fibrillation, an intellamap orion catheter was used in the pulmonary veins.It was noted that liquid entered the tail end of the device and could not be displayed properly on the system.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient's condition following the procedure was reported to be stable.The device is expected to be returned for analysis.
Event or Problem Description
It was noted that liquid entered the tail end of the device and could not be displayed properly on the system.During an ablation procedure to treat atrial fibrillation, an intellamap orion catheter was used in the pulmonary veins.It was noted that liquid entered the tail end of the device and could not be displayed properly on the system.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient's condition following the procedure was reported to be stable.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Correction to the initial mdr in blocks e1 (initial reporter zip/post code) and h6 (device codes).E1: initial reporter's facility name is (b)(6); reported here as the facility name exceeded character limit for designated field.Investigation summary: with all the available information, boston scientific concludes that the reported events of catheter handle leak and system tracking accuracy issue could not be confirmed, as no device problems were identified during analysis.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: upon receipt at post market quality assurance laboratory, the intellamap orion catheter was visually inspected, and no visible problems were noted.Functional testing revealed that the catheter's functional mechanism worked properly; no abnormal resistance was felt when actuating the device.During flow testing, the device was connected to a metriq pump and was purged at 60ml/min; a free flow was observed.Continuity testing was performed, and the device was found within specifications.Electrical testing was also performed, and the device was recognized by rhythmia mapping system without any problems.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the intellamap orion catheter risk documentation was completed and confirmed that the events of catheter handle leak and system tracking accuracy issue were 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: boston scientific has assigned an investigation conclusion code of no problem detected, as the investigation findings confirmed that no problems were identified with the device.

• 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: 23850552
• Report Number: 2124215-2025-92015
• Device Sequence Number: 18523482
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968(17)261226(10)36844459
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K220796
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M004RC64S0
• Device Catalogue Number: M004RC64S0
• Device Lot Number: 0036844459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 79 KG