MAUDE Adverse Event Report: MEDTRONIC, INC. AFFERA; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH

Model Number	AFR-00008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cardiac ablation procedure, the catheter disappeared and then reloaded.After finishing the pulmonary vein isolation (pvi), the catheter was removed from the patient, and the catheter would be reinserted into the patient after the deployment of a left atrial appendage (laa) closure device from another manufacturer.Once the catheter was outside of the patient, a temperature sensor fault error occurred.Multiple troubleshooting steps were attempted several times, including pacing from the catheter and effected electrode, flushing the catheter, restarting the system and workstation multiple times, unplugging and re-plugging in the catheter extension cable.Despite replacing the catheter twice (using a total of three catheters) and replacing the catheterextension cable twice, the error could not be resolved.Technical services requested that the gen link cables be switched and plug the catheter extension cable directly into the that gen link port which did not resolve the issue.The physician decided to stop troubleshooting and aborted the case without performing the cavotricuspid isthmus (cti) line.The patient was under general anesthesia, and ablation was possible during the procedure prior to the event.Technical services recommended a service visit.No patient comp lications have been reported as a result of this event.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was later reported that additional errors were received indicating the return 1 contact quality was invalid and that there was a temperature acquisition circuit failure.
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The log files were reviewed using the affera log file analysis tool.In conclusion, the reported "catheter temperature sensor fault, return 1 contact quality poor, temperature acquisition circuit failure, and location reference not calibrated" issues were confirmed through data analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: AFFERA
• Common Device Name: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH
• Manufacturer (Section D): MEDTRONIC, INC.; 880 technology park drive; billerica MA 01821
• Manufacturer (Section G): MEDTRONIC, INC.; 880 technology park drive; billerica MA 01821
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24497797
• Report Number: 3012520654-2026-00080
• Device Sequence Number: 9960165
• Product Code: QZI
• UDI-Device Identifier: 00763000871925
• UDI-Public: (01)00763000871925(11)250630
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P240013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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: AFR-00008
• Device Catalogue Number: AFR-00008
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: Not provided; 03/24/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/05/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown