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	Heart Block (4444)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a heart block and was implanted with a permanent pacemaker.During an atypical atrial flutter, an intellamap orion mapping catheter and farawave catheter were selected for use.A comprehensive right atrial map was created using the orion catheter.A his cloud was created with the opal mapping system to confirm a safe distance between the planned lesion set and the conduction system.A farawave nav 31 mm catheter was then advanced.The ablation strategy targeted the anterior right atrial floor near the tricuspid valve, approximately at the 5 o'clock position.The catheter was deployed in a flower configuration, and six pfa applications were delivered in this region.The tachycardia cycle length progressively slowed with each application.Following the sixth pulse, the atrial tachycardia terminated, however, the patient went into complete heart block.Ventricular conduction was no longer present, and atrial activity continued at a fixed non tachycardic rate.Based on the physician assessment, the device and procedure did not contribute to the adverse event.A non boston scientific catheter was advanced to facilitate ventricular pacing.During setup, an issue was encountered with signal acquisition.The egm cable was initially connected to the mab block using pins 1 10 for the cs catheter and functioned normally.Pins 11 14 were then connected to the mab block, and the catheter cable pins were connected to the farastar egm block, however, no signals were obtained.A different 4 pin configuration was used on the mab block and configured within the recording system.After directly connecting the catheter cable to the mab block, intracardiac signals were successfully acquired.The cable was replaced.While troubleshooting was underway, the patient was successfully paced in the right ventricle using the cs catheter.The patient was administered isuprel, after which atrioventricular (av) conduction returned.The physician noted that the patient had pre existing diseased av conduction.Due to the complete heart block event and underlying conduction disease, a permanent pacemaker was subsequently implanted.
Additional Manufacturer Narrative
G4 premarket / 510(k) #: k143481, k192360, k220796.

• 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: 50263487
• Report Number: 2124215-2026-41673
• Device Sequence Number: 10020422
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968(17)271111(10)39323325
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 0039323325
• 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: 07/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 05/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FARAWAVE PFA Catheter
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown