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 Code	Ventricular Fibrillation (2130)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cardiac ablation procedure, ventricular fibrillation occurred on the first and second radiofrequency (rf) lesions of the cavotricuspid isthmus (cti) line, necessitating defibrillation each time.The procedure was switched to pulsed field (pf) ablation for the remaining lesions on the cti line, which proceeded without further issues.The case was completed.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product event summary: the afr-00001 ablation catheter with lot number 0230018839 was returned and analyzed.During external visual inspection, no visible defects were seen.The catheter was functionally tested with test capital equipment.Testing for radiofrequency (rf) and pulsed field ablation did not show any errors and temperatures appeared normal.Mapping was able to be completed with the catheter as well.Cirris tester was used to run the shorts and mapping tests and the device had passing results.Breakout fixture was used but no shorts to the braid were identified.The clinical issue occurred during the procedure.There is no indication of a relation of the adverse event to the performance or a malfunction of the product.In conclusion, the catheter did not fail the returned product inspection.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: 21283668
• Report Number: 3012520654-2025-00009
• Device Sequence Number: 12739811
• Product Code: QZI
• UDI-Device Identifier: 00763000871741
• UDI-Public: 00763000871741
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/03/2025

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 Expiration Date: 12/12/2025
• Device Model Number: AFR-00001
• Device Catalogue Number: AFR-00001
• Device Lot Number: 0230018839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Male