MAUDE Adverse Event Report: Medtronic Ireland Sphere-9; 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that  during a cardiac ablation procedure, during pulsed-field delivery of the first application after creation of a post map, the sphere 9 catheter displayed a hashed appearance with bright electrodes, the green impedance graph was maximized, and the catheter was not displayed properly on the affera system.After disconnecting and reconnecting the sphere 9 catheter, it was nolonger visualized on the affera system.Troubleshooting included rebooting the affera system, magnet and then replaced cables, sphere 9 catheter and patches, moved the patient table and imaging equipment, but the issue persisted.The procedure was aborted and not continued using another system.An engineer tested the system the following day and was unable to reproduce the lack-of-visualization issue; the system functioned properly during testing.No patient complications have been reported as a result of this event.2026-09-25 it was later reported that the case was aborted under general anesthesia.
Additional Manufacturer Narrative
Continuation of d10: product id: afr-00016, product type: mapping system.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: Sphere-9
• Common Device Name: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH
• Manufacturer (Section D): Medtronic Ireland; parkmore business park west; galway ; EI
• Manufacturer (Section G): Medtronic Ireland; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50895801
• Report Number: 9612164-2026-04838
• Device Sequence Number: 10684662
• Product Code: QZI
• UDI-Device Identifier: 00763000973506
• UDI-Public: (01)00763000973506(17)270114(10)0013184521(20)01
• 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
• Report Date (Section B): 09/25/2026

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: 0013184521
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 12/15/2025
• 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: Other
• Patient Sex: Male