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	Compatibility Problem (2960); Infusion or Flow Problem (2964); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: 990063-020, product type: mapping catheter product event summary: the patient data files and the 2af284 balloon catheter with lot number 16641 were returned and analyzed.The patient file showed eight applications were performed using a 2af284 balloon catheter with lot number 16641 and four applications were performed using a 2af284 balloon catheter with lot number 16954.The patient file showed system notice 50028 (there is a problem with the injection process) during the inflation at application one and system notice 50012 (the refrigerant delivery path is obstructed) during the translation at applications two, three, and four.The console output data (pressure, preset pressure, temperature, and flow) showed earlier balloon deflation during the thawing phase at applications six, seven, and nine.External visual inspection showed the balloon was bent.Review of the smart chip data indicated the catheter was used for eight 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 the temperature curve had no oscillation or overshoot.The mapping catheter was unable to be retracted from the balloon catheter; the mapping catheter was stuck inside balloon catheter guidewire lumen.Pressure testing and dissection revealed a guidewire lumen kink/twist 0.9 inches proximal to the catheter tip.Pressure testing did not identify any leakage from the kink.In conclusion, the balloon catheter did not pass the returned product inspection due to a kink/twist observed on the guidewire lumen.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 procedure involving a mapping catheter and a balloon catheter, the mapping catheter was unable to be manipulated inside the balloon catheter, and it could not move forward or backward, leading to physical damage.There were also issues inserting the mapping catheter into the balloon catheter.Additionally, the balloon catheter experienced general early deflation and pressure/flow issues.The mapping catheter and balloon catheter were both replaced to resolve these issues.The procedure was completed with cryo.It was noted that it was hard to manipulate the mapping catheter and it was believed that the mapping catheter was kinked.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: 21267083
• Report Number: 2649622-2025-02993
• Device Sequence Number: 18255448
• Product Code: OAE
• UDI-Device Identifier: 00763000431532
• UDI-Public: 00763000431532
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/29/2025

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: 12/22/2024
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 16641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Male