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

Model Number	AFAPRO23
Medical Device Problem Codes	Material Integrity Problem (2978); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: afapro28 product type: balloon catheter product id: 203cx product type: coaxial umbilical cable product event summary: the afapro23 balloon catheter of lot number 17732 was returned and analyzed.External visual inspection of the balloon, shaft, and handle segments was carried out.External visual inspection of the balloon segment showed a leak path from the outer balloon.The outer balloon proximal bond was partially detached from the catheter shaft.External visual inspection of the balloon segment showed fluid inside the balloon.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for 15 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice #50005 indicating that the safety system detected fluid in the catheter and stopped the injection.Pressure testing and inspection of sub-components of the balloon, handle, and shaft segments.Pressurizing of the outer balloon identified the outer balloon proximal bond was leaking and detached from the shaft.During inspection of the handle segment, liquid was observed inside handle.In conclusion, the balloon catheter failed the return product inspection due to the outer balloon proximal bond partially detaching from the catheter shaft.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 during a cryo ablation procedure, a system notice was received indicating that the safety system detected a compromised outer vacuum.Continue was pressed and tried to freeze again, without resolution.The vacuum was released and a system flush was performed, but then a system notice was received indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled.The balloon catheter was replaced, but then the first two system notices were received again, a system notice was received indicating that the safety system detected fluid in the console and the system was inoperable, and a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection."everything was removed," but then a system notice was received indicating that the safety system detected fluid in the console and the system in inoperable.Fluid was found in the coaxial umbilical cable and on the coaxial port of the console.The case was completed with cryo.Test ablations were later performed with a new balloon catheter and coaxial umbilical cable, and no issues were observed.No patient complications have been reported as a result of this event.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21909141
• Report Number: 2649622-2025-11272
• Device Sequence Number: 8795235
• Product Code: OAE
• UDI-Device Identifier: 00763000707774
• UDI-Public: 00763000707774
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/25/2025

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 Expiration Date: 03/12/2025
• Device Model Number: AFAPRO23
• Device Catalogue Number: AFAPRO23
• Device Lot Number: 17732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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: Unknown