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	Heart Block (4444)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the afr-00001 affera¿ sphere-9¿ catheter with lot 0233235815 and data files were returned and analyzed.The log files were analyzed, and timestamps/errors were observed with catheter serial number (b)(6).During external visual inspection, the catheter was found to be intact, and no defects were observed.The cirris tester was used on the catheter for shorts and mapping tests, and the tests passed successfully.The catheter was functionally tested using test capital equipment.Radiofrequency (rf) and pulse field ablations were completed successfully with the catheter.A new map was started, and the catheter was able to map appropriately.In conclusion, the reported clinical issues cannot be assessed through data analysis.The catheter passed the returned product inspection per specification.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 reported that an affera mapping system with a sphere 9 catheter was used during a ventricular tachycardia ablation, two ventricular tachycardia morphologies were induced with suspected origin from the inferior septum of the left ventricle, and premature ventricular contractions were described as a suspected trigger for ventricular tachycardia or ventricular fibrillation.A scar map was created during right ventricular lead pacing and left ventricular scar homogenization was performed on the inferior and septal walls, including lesion delivery at the inferior basal septum and at the left posterior fascicle based on mapped signals including purkinje potentials.Pulsed field ablation and radiofrequency ablation lesions were delivered, and complete type 3 heart block was later recognized after ablation performed under left ventricular pacing, with a concern that the posterior fascicle may have been the only remaining conduction pathway.The procedure was aborted while the patient was under general anesthesia after recognition of complete heart block, and another manufacturer's biventricular implantable cardioverter defibrillator was implanted.No further patient complications have been reported as a result of this event.

• 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: 25228811
• Report Number: 3012520654-2026-00221
• Device Sequence Number: 5105224
• Product Code: QZI
• UDI-Device Identifier: 00763000973391
• UDI-Public: (01)00763000973391(17)270315(10)0233235815
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/20/2026

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: 0233235815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2026
• 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: 71 YR
• Patient Sex: Male