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

Model Number	AFR-00001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Swelling/ Edema (4577)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: afr-00004 product type: radiofrequency generator 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 reported that during a cardiac ablation procedure, power startup issues occurred when the remote powered down without cause twice, requiring the procedure to be paused and the remote to be restarted and reestablished as the primary unit.During delivery of radiofrequency energy, the electrocardiogram on the anesthesia monitor flatlined, but normal electrocardiogram recordings returned after radiofrequency energy was turned off.No other electrocardiogram equipment in the room appeared affected by radiofrequency energy.Electrocardiogram monitoring was conducted throughout the procedure.The case was completed.The patient experienced pain and swelling around the right forearm near the procedural arterial line.Later in the night, pain and swelling increased.Ultrasound was performed and a hematoma clot was observed.The next day, the patient was taken in for a decompressive fasciotomy on the right hand.Patient was hospitalized until february 11th.It was also reported that the patient was going to have an implantable cardioverter defibrillator (icd) upgrade and ra lead revision.No further patient complications have been reported as a result of this event.

• 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: 24511432
• Report Number: 3012520654-2026-00083
• Device Sequence Number: 9869883
• Product Code: QZI
• UDI-Device Identifier: 00763000973391
• UDI-Public: (01)00763000973391(17)261127(10)0232551387
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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-00001
• Device Catalogue Number: AFR-00001
• Device Lot Number: 0232551387
• 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: 02/02/2026
• Initial Report FDA Received Date: 03/04/2026
• Date Device Manufactured: 10/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male