MAUDE Adverse Event Report: Cortex Inc. OptiMap?; catheter, electrode recording, or probe, electrode recording

Model Number	OPTI-CATH-50
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure to treat persistent atrial fibrillation, a farawave nav catheter and an optimap cortex catheter were used.The left atrial portion of the procedure was completed using the farawave catheter after pulmonary vein treatment.The farawave catheter was then removed, and the optimap catheter was inserted to visualize sources above 25%.The left atrial portion was completed without issue.After repositioning the faradrive sheath into the right atrium and reintroducing the farawave catheter, the patient experienced an approximately 15-second episode of heart block during right atrial mapping.Ventricular rhythm returned spontaneously without intervention, and mapping was continued with caution.The farawave catheter was exchanged for the optimap cortex catheter.The first optimap image set was successfully obtained, and three sources were ablated.When optimapping was attempted again, the optimap catheter could not be visualized.Troubleshooting was performed, including verification of all system connections and restarting the opal session, but visualization could not be restored.The optimap catheter was removed, and the farawave catheter was reinserted to recreate a new right atrial field map.The farawave catheter was again exchanged for the optimap catheter.The first post-ablation map displayed an additional source, although the map appeared slightly shifted.The physician proceeded with treatment based on the marked location.A second set of post-procedure maps was attempted, but the optimap catheter again failed to visualize.For patient safety, the procedure was stopped early, and the final post-procedure maps were not completed.The patient recovered fully without further issues.

• Brand Name: OptiMap?
• Common Device Name: catheter, electrode recording, or probe, electrode recording
• Manufacturer (Section D): Cortex Inc.; 3350 scott blvd, suite 37b; santa clara CA 95054
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 25513238
• Report Number: 2124215-2026-31918
• Device Sequence Number: 9940263
• Product Code: MTD
• UDI-Device Identifier: 00850064686067
• UDI-Public: (01)00850064686067
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPTI-CATH-50
• Device Catalogue Number: OPTI-CATH-50
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 06/08/2026; 09/24/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 06/29/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FARAWAVE CATHETER - BSC; FARAWAVE CATHETER - BSC
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 189 LB