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

Model Number	M004RC64S0
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a material tear occurred.A pulse field ablation (pfa) procedure for pulmonary vein isolation was performed using a farawave catheter and intellamap orion catheter.The intellamap orion catheter was used to acquire pre and post ablation maps of the left atrium.Pre mapping of the right atrium near the superior vena cava was completed and ablation was performed.During post mapping of the right atrium the coating of the intellamap orion catheter at the flexion point was found to be torn.The intellamap orion catheter was replaced with a new intellamap orion catheter and the procedure successfully concluded.No patient complications were reported.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device history record review: a review was completed of the device history records (dhr) for the intellamap orion catheter upn #m004rc64s0 batch #0038011897.The intellamap orion catheter was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformances that could have contributed to the event.Device technical analysis: the intellamap orion catheter was discarded at the healthcare facility, therefore returned device analysis could not be performed.Labeling review: there was no evidence to suggest the device was used in a manner inconsistent with the labeling.Investigation conclusion: bsc has assigned an investigation conclusion code of unable to exclude device problem.It was reported that during a pulse field ablation procedure a material tear was identified on the intellamap orion catheter while the catheter was in the patient anatomy.The procedure was completed using a new intellamap orion catheter.As the device was not returned for analysis, the reported material tear could not be confirmed.Risk review: a review of the orion hazard analysis was completed and confirmed that the event of catheter shaft tears/rips/holes/separated device material 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.
Event or Problem Description
It was reported that a material tear occurred.A pulse field ablation (pfa) procedure for pulmonary vein isolation was performed using a farawave catheter and intellamap orion catheter.The intellamap orion catheter was used to acquire pre and post ablation maps of the left atrium.Pre mapping of the right atrium near the superior vena cava was completed and ablation was performed.During post mapping of the right atrium the coating of the intellamap orion catheter at the flexion point was found to be torn.The intellamap orion catheter was replaced with a new intellamap orion catheter and the procedure successfully concluded.No patient complications were reported.

• 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: 24415305
• Report Number: 2124215-2026-09791
• Device Sequence Number: 5939253
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968(17)270523(10)38011897
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/30/2026

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: 0038011897
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 11/21/2025
• 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 Sex: Unknown