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

Model Number	2AF234
Medical Device Problem Code	Excessive Cooling (2932)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: d10/h11 continuation of d10: product id: (b)(4), product type: balloon catheter 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 temperatures were fluctuating erratically and the temperature dropped more quickly than expected, despite balloon placement in a warmer region of the heart.The auto connection box was replaced without resolution.The balloon catheter was replaced with one of the same lot, and the issues persisted.The balloon catheter was replaced again with one of a new lot 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
Continuation of d10: product id: 2af284, product type: balloon catheter product event summary: no anomalies were identified during external visual inspection of the balloon, shaft, and handle segments.Review of the catheter smart chip data indicated the catheter was used for five applications on the reported event date.The catheter was recognized and passed electrical integrity and performance testing.The catheter completed the inflation, ablation, and thawing phases with no console system notices generated.No performance issues were identified.The pressure and flow were in range and temperature curve had no oscillation or overshoot.In conclusion, the reported "temperature dropped rapidly" was not observed/reproduced with the catheter, which passed returned product inspection per specification.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 patient data files were returned and analyzed.No case file was available for analysis; however, the foll owing fault messages were found in the fault files on the reported event date: n-018 (the system has detected an unexpected temperature or loss of temperature reading from the catheter), n-027 (the system has detected an unexpected temperature during system flush), n-048 (the system has detected a compromised balloon prior to ablation), and n-184 (the system has detected a higher than expected pressure).In conclusion, the reported issue was confirmed during analysis and fault messages were observed.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: 20695911
• Report Number: 2649622-2024-30875
• Device Sequence Number: 6556105
• Product Code: OAE
• UDI-Device Identifier: 00763000431518
• UDI-Public: 00763000431518
• 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,Followup,Followup
• Report Date (Section B): 12/18/2024

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: 02/09/2025
• Device Model Number: 2AF234
• Device Catalogue Number: 2AF234
• Device Lot Number: 14789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 11/26/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 11/15/2024; 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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...; SEE H11...
• Patient Age: 66 YR
• Patient Sex: Male