MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	AFAPRO28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cryoablation procedure, the left sided veins were isolated and, while cryoablation therapy was administered on the right sided veins, loss of diaphragm stimulation for the phrenic nerve occurred.The physician requested that therapy be stopped, and cryotherapy was immediately discontinued.Phrenic nerve injury was identified, and phrenic nerve activity had not returned at the conclusion of the case.The case was completed with cryo.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: clinical data was received and analyzed.The received pdf file includes the event date as well as statistical and demographic information related to the case.It contains detailed cryoablation treatment logs, but does not contain any records of system notifications, alerts, or phrenic nerve/diaphragm related issue during the procedure.The catheter is identified as arctic front advance pro¿ 28 mm, with lot number 23568 and serial number 6.The cryoconsole id is n2422a0216.The procedure date is recorded as 11/7/2025.In conclusion, the physical product was not received.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: ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23737982
• Report Number: 2649622-2025-34095
• Device Sequence Number: 20965388
• Product Code: OAE
• UDI-Device Identifier: 00763000707781
• UDI-Public: (01)00763000707781(17)260109(10)23568
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100010
• 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): 12/06/2025

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 Expiration Date: 01/09/2026
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 23568
• 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: 11/07/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 50 KG