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 Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cardiac ablation procedure, activated clotting time was 371 seconds prior to catheter inserted into the body.Transeptal was performed with another manufacturer guidewire and sheath.Left atrial mapping was performed while the patient was in atrial fibrillation.The patient underwent synchronized cardioversion at 360 joules and rapidly returned to atrial fibrillation and atrial flutter.An antiarrhythmic medication was administered.The heart rate decreased below 50 beats per minute, and pacing was initiated from the coronary sinus catheter.The blood pressure reading was lost.It also noted that the cause for low blood pressure and heart rate is unknown.Pulse could not be felt in the jugular area.Cardiopulmonary resuscitation, compression was performed.Intracardiac echocardiography (ice) showed no pericardial effusion, venography showed no femoral vein or artery issues, and laboratory testing was reported as normal.An arterial pressure line was inserted, and pressure stabilized.  the patient was hemodynamically stable at the end of the procedure, remained on a ventilator, and was sent for computed tomography (ct) imaging to rule out stroke.The procedure was aborted and was not continued with the other system.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 id: non-medtronic product product type: sheath 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: 50799475
• Report Number: 9612164-2026-04657
• Device Sequence Number: 13407031
• Product Code: QZI
• UDI-Device Identifier: 00199150003709
• UDI-Public: (01)00199150003709(17)270409(10)0013333882(20)01
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/17/2026

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: 0013333882
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 03/10/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 267 LB