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

Model Number	AFAPRO28
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: afapro28, product type: balloon catheter; product id: nitron, product type: console.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.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, while carrying out the first freeze a an error message was received indicating that there was blood detected at the catheter handle.And an error message was received indicating that there was blood detected at the patient board (catheter shaft impedance wire blood detection).The coaxial umbilical cable, electrical umbilical cable and auto connection box were replaced without resolve.The balloon catheter was replaced to resolve the first system notice.The second balloon catheter and console were replaced to resolve the second. the case was completed with cryo.After the case, it was noted that there was visible blood between the layers of the first balloon catheter.Test injections were carried out with a demo balloon catheter and cables and the console was noted to be functioning as expected. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.One case file received and recorded on the reported event date.The case file showed one application was performed with catheter identified as afapro28 of lot number 23243 without any system notice or anomaly.In the fault file, the following fault messages were found on the reported event date: n-004 the system has detected blood in the catheter handle and stopped the vacuum.N-006 the system has detected blood in the catheter.In conclusion, both system notices were observed in the data files.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.
Additional Manufacturer Narrative
Product event summary: the afapro28 balloon catheter with lot number 23243 was returned and analyzed.External visual inspection showed blood inside the balloon.Review of the smart chip data indicated the catheter was used for 1 application on the reported event date.During functional testing, the console terminated the application and triggered system notice n-004 (the system detected blood in the catheter handle and stopped the vacuum).During inspection of the handle segment, blood was observed inside handle.During pressure testing of the balloon segment, an outer balloon breach was observed.Dissection of the balloon segment identified an outer balloon breach (pinhole type).In conclusion, the reported visible blood was confirmed during analysis.The catheter did not pass the returned product inspection due to pin-sized hole on the surface of the outer balloon.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): 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: 21167115
• Report Number: 2649622-2025-01747
• Device Sequence Number: 15805776
• Product Code: OAE
• UDI-Device Identifier: 00763000707781
• UDI-Public: 00763000707781
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup,Followup
• Report Date (Section B): 04/09/2025

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: 11/27/2025
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 23243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 01/22/2025; 03/12/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/18/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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: Female