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

Model Number	2AF284
Medical Device Problem Code	Excessive Cooling (2932)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.Product event summary: the data files and 2af284 balloon catheter with lot number 06845 were returned and analyzed.The data files were analyzed using the applicable console software per the applicable field service manual.Patient files showed at least 16 applications were performed on the day of the event.The files showed at least 4 applications were performed with the returned balloon catheter.The flow and pressure are within range but the temperature reached below -70 degrees celsius on application #2 and reached -57 degrees celsius within 32 seconds on application #3.Patient files showed at least 12 applications were performed with a non-returned balloon catheter.The flow and pressure are within range but the temperature reached below -61 degrees celsius on application #5 and #6.No anomalies were identified during external visual inspection of the balloon, shaft, and handle segments.The catheter smart chip data was reviewed.Data indicated the catheter was never used; however, the data files showed the catheter was used.During functional testing, a sudden temperature drop was observed at the beginning of the ablation phase.The ablation temperature was very cold (below -70 degrees celsius).The inflation, ablation, and thawing phases were completed.No console system notices were generated.Pressure testing and inspection were performed on the sub-components of the balloon, handle, and shaft segments.During ins pection of the shaft segment, a scratched injection tube was identified inches from the catheter tip.The injection tube may be cracked in that region.In conclusion, the reported issue of the temperature dropping faster than expected was confirmed through testing.The balloon catheter failed the returned product inspection due to the injection tube fracture/tear observed at the shaft segment.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, the temperature dropped faster and colder then expected.The balloon catheter was replaced to resolve the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.

• Brand Name: ARCTIC FRONT ADVANCE® 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: 20428301
• Report Number: 2649622-2024-27151
• Device Sequence Number: 7590050
• Product Code: OAE
• UDI-Device Identifier: 00763000341480
• UDI-Public: 00763000341480
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/11/2024

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: 10/28/2023
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 06845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Male