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 Codes	Leak/Splash (1354); Excessive Cooling (2932); Infusion or Flow Problem (2964); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cryo ablation procedure, the flow was higher than expected, there were temperature overshoots, and frost forming on the coaxial connection.It was also reported that a system notice was received indicating that the vacuum was disabled due to a problem with the coaxial umbilical cable.The balloon catheter was replaced which resolved the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.
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 09662 were returned and analyzed.The files were analyzed using the applicable console cdm software per the applicable field service manual.Three patient files were received and recorded on the reported date of the event.The first file showed ten applications were performed with a non-returned balloon catheter.The second file showed nine applications were performed with another non-returned balloon catheter.The third file shows seven applications using the returned balloon catheter and then nine applications with another non-returned balloon catheter.The third file also showed 50001 "the vacuum was disabled due to a problem with the coaxial umbilical cable" during ablation on the sixth application with a non-returned balloon catheter.The third file also showed console output data with unexpected pressure and flow profiles during the ablation phase of the first through sixth applications.No anomalies were identified during external visual inspection of the balloon, shaft, and handle segments.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for seven applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50030 "a high level of refrigerant flow and stopped the injection." the coaxial port was detached from the handle and was pressurized from injection tube at coaxial port while the free side of injection tube was blocked at the other side.Pressure testing showed the bubbles are coming out from the coaxial port.It identified a leak path at the bonding location of the injection tube and coaxial connector.Frost was noted on the coaxial connector.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 a leak observed at the injection tube through the coaxial connector adhesive.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® 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: 20473230
• Report Number: 2649622-2024-27797
• Device Sequence Number: 7353324
• Product Code: OAE
• UDI-Device Identifier: 00763000341480
• UDI-Public: 00763000341480
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/17/2024

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: 06/05/2024
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 09662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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 Sex: Unknown