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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the afr-00016 impedance mapping system and the sphere 9 catheter in a cardiac ablation procedure, the mapping system experienced a software issue where a labeled tag was dropped instead of the intended electrical tag, a delay in executing the fast remap function, a generator central processing unit (cpu) high usage alert, and a delay in fast remap.The f5 function brought up a window that obstructed the screen, the mouse wheel was unable to scroll in drop-down menus, and the "add tag to anatomy" option was no longer available.Additionally, pulse3 commented on every pulse field lesion, blocking useful tagging.While ablating on the inferior vena cava (ivc) side of the ridge during radiofrequency ablation of the cavotricuspid isthmus (cti), a steam pop was identified by the physician, who could feel, smell, and see the event on intracardiac echocardiography (ice).The lesion graph indicated a drop in temperature and a spike in current halfway through the ablation.The case was completed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id afr-00016 (serial: (b)(6)); product type: 2004-mapping hardware.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.
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.
Additional Manufacturer Narrative
Product event summary: an image file and the clinical data files were returned and analyzed.Image file review showed a heart on an anatomical map with pulsed field and radiofrequency lesion tags.Clinical data review was completed leveraging the completion of design assessment.The reported incorrect tag label placement behavior is consistent with a known anomaly whereby customer electrical tag presets are initially placed with the incorrect name when tagging.The reported lag behavior during fast remap is consistent with a known anomaly whereby noticeable lag follows certain mapping-related actions throughout a case.The reported "pulse3" comment on every lesion behavior is consistent with a software anomaly whereby the lesion graph comments have preset names prefilled.In conclusion, the reported issue of steam pop was determined to be plausible following data analysis.The catheter was discarded and will not be returned for analysis.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: 24676388
• Report Number: 3012520654-2026-00108
• Device Sequence Number: 15977996
• Product Code: QZI
• UDI-Device Identifier: 00763000973391
• UDI-Public: (01)00763000973391(17)261211(10)0232667198
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 0232667198
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 04/21/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/23/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2025
• 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...
• Patient Sex: Male