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	Atrial Fibrillation (1729); Bradycardia (1751)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post-operatively an index procedure using the sphere-9 catheter, the patient experienced atrial fibrillation reoccurrence documented on electrocardiograms, including recurrence after electrical cardioversion.The patient presented to the cardiac lab unit for transesophageal echocardiography and electrical cardioversion, and transesophageal echocardiography showed no left atrial appendage thrombus; an ep study was performed and cardioversion returned the rhythm to sinus rhythm, but atrial fibrillation recurred approximately 30 minutes later, and the patient was discharged the same day.Oral anti-arrythmic medication was initiated for atrial fibrillation recurrence.The patient later returned for additional electrical cardioversions with 200j external biphasic energy, with return to sinus rhythm followed by recurrence of atrial fibrillation minutes later, and sinus bradycardia was also documented on electrocardiogram; oral beta-blocker medication was discontinued.A subsequent cardioversion for recurrent atrial fibrillation again returned the rhythm to sinus rhythm, and electrocardiograms documented atrial fibrillation and sinus bradycardia.The events were reported as recovered/resolved.No further patient complications 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.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: 24830870
• Report Number: 3012520654-2026-00159
• Device Sequence Number: 9168998
• Product Code: QZI
• UDI-Device Identifier: 00763000973391
• UDI-Public: (01)00763000973391(17)260728(10)0231692952
• Combination Product (Y/N): N
• 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): 04/09/2026

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: 0231692952
• 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: 03/13/2026
• Initial Report FDA Received Date: 04/09/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White