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	Atrial Fibrillation (1729)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cardiac ablation procedure, the electrode p3 on the catheter showed a constant high temperature reading after the device was removed and reinserted into another manufacturer's transeptal sheath, and following cardioversion post left atrial ablations in response to atrial fibrillation (af).Troubleshooting was performed, including trying a new ablation cable, which did not resolve the issue.The catheter was replaced to complete the right atrial cavo-tricuspid isthmus (cti) ablation, with no further issues reported.The case was completed.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id: non-medtronic product, product type: sheath.Product event summary: the afr-00001 sphere 9 catheter with lot 0232479409 and data files were returned and analyzed.The received image demonstrates a system notification: "catheter temperature sensor fault" on the affera workstation screen.The log files were analyzed, and timestamps/errors were observed.During external visual inspection, the catheter was found to be intact, and no defects were observed.The cirris tester was used to perform shorts and mapping tests, which resulted in a failure.An open circuit was identified at p3 and p4 electrodes in zone 1 of the catheter.An optical inspection of the lattice structure was conducted, revealing broken wires at p3, as well as insulation damage at p4.In conclusion, the reported clinical issues cannot be assessed through analysis.The temperature issue was observed through data analysis.The catheter failed the returned product inspection due to an open circuit.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: 24689313
• Report Number: 3012520654-2026-00113
• Device Sequence Number: 21264117
• Product Code: QZI
• UDI-Device Identifier: 00763000973391
• UDI-Public: (01)00763000973391(17)261117(10)0232479409
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 03/25/2026

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: 0232479409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 10/18/2025
• 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: Required Intervention
• Patient Sex: Unknown