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

Model Number	AFR-00001
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pulmonary Edema (2020); Heart Block (4444)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post-operatively to a completed cardiac ablation procedure, reported to the hospital with complaints of abdominal pain.The patient was hospitalized and discharged home two days later.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.On (b)(6) 2026: it was later reported that the cardiac ablation procedure was two days prior to the patient reporting to the hospital with abdominal pain.(b)(6) 2025: it was later reported that two consecutive steam pops occurred intraoperatively a cardiac ablation procedure.The catheter was removed and char/thrombus formation was observed on the catheter.The catheter was replaced.Another steam pop occurred.As a result of ablation this area, the patient developed left bundle branch block (lbbb).A transesophageal echocardiogram and chest x-ray were performed.
Additional Manufacturer Narrative
Continuation of d10: product id: afr-00001 product type: catheter 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 the patient was admitted for acute exacerbation of combined systolic and diastolic congestive heart failu re.The patient received an upgraded device.In the emergency department the patient was found to have an elevated probnp of 2394.Troponin was elevated at 25,000.The patient had a mildly elevated creatinine of 1.4.Chest x-ray showed worsening bibasilar opacities concerning for pneumonia.Cta of the chest showed cardiomegaly with mild pulmonary edema.The patient was admitted to the hospital for monitoring on telemetry, trending troponin.The patient is started on iv diuretic medication.A repeat echocardiogram was obtained showed an ef of 20% with severe diastolic dysfunction.Troponin has trended down.
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: 24890771
• Report Number: 3012520654-2026-00167
• Device Sequence Number: 9835123
• Product Code: QZI
• UDI-Device Identifier: 00763000973391
• UDI-Public: (01)00763000973391(17)261012(10)0232246750
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 05/05/2026

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: AFR-00001
• Device Catalogue Number: AFR-00001
• Device Lot Number: 0232246750
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/05/2026
• Date Device Manufactured: 09/12/2025
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 104 KG