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 Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the afapro28 balloon catheter with lot number 23314 was returned and analyzed.External visual inspection of the shaft segment showed a kink/twist approximately 3.25 inches from the tip.Review of the smart chip data indicated the catheter was used for 16 applications on the reported event date.The catheter was recognized and passed the electrical integrity verifications and performance tests.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.During inflation, a kinked guidewire lumen was observed inside the balloon segment.Insertion of the mapping catheter failed due to the kinked guidewire lumen.During inspection of the shaft segment, a guide wire lumen kink/twist was observed 1 inch proximal to the catheter tip.Pressure testing did not identify any leakage from the kink.In conclusion, the balloon catheter failed the returned product inspection due to a kink/twist observed on the guide wire lumen and a kink/twist observed on the shaft.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 cardiac ablation procedure, there were issues with inserting the mapping catheter into the balloon catheter.Post ablation, the balloon catheter was removed from the patient in order to post map and check pulmonary vein isolation.Upon attempting to reinsert the balloon catheter for further ablations, the catheter became difficult to pass through the flexcath sheath.A kink was observed in the balloon catheter near the distal end.The balloon catheter was re-prepped but then the mapping catheter would not advance to the end of the balloon.A kink was also noted in the mapping catheter when removed.Both the balloon and mapping catheters were replaced.The case was completed with cryo.No patient complications have been reported as a result of this event.

• 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: 21930099
• Report Number: 2649622-2025-11583
• Device Sequence Number: 13033169
• Product Code: OAE
• UDI-Device Identifier: 00763000707781
• UDI-Public: 00763000707781
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/29/2025

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: 12/10/2025
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 23314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/29/2025
• Date Device Manufactured: 12/10/2024
• 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: PRODUCT ID: 2ACH15, PRODUCT TYPE: MAPPING CATHETER
• Patient Age: 52 YR
• Patient Sex: Male