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	Excessive Cooling (2932); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
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 the 2af284 balloon catheter with lot number 08185 were returned and analyzed.One patient file was received and recorded on the reported date of the event.The patient file showed 25 applications were performed using a catheter identified as 2af284 with lot number 8185.The patient file did not show any system notices on the reported date of the event.The console output data (pressure, preset pressure, and flow) did not show any temp artifacts.Pressure was tracking preset pressure and flow readings which were as expected.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 25 applications on the reported event date.During functional testing, temperature fluctuation was observed during the ablation phase.The inflation, ablation, and thawing phases were completed.No console system notices were generated.During inspection of the balloon segment, an inner balloon distal neck/gwl bond length tolerance stackup issue was observed.During inspection of the balloon segment, foreign debris was observed at the laser drilled hole(s) of the injection tube.In conclusion, the reported only one side of the balloon catheter was developing ice formation issue could not be assessed through data analysis.The reported issue of the temperature dropping faster than expected was not confirmed through testing.However, the temperature fluctuations were confirmed through testing.The balloon catheter failed returned product inspection due to an inner balloon distal neck/gwl bond length tolerance stackup issue and foreign debris at the laser drilled hole(s) of the injection tube.R 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, temperatures were fluctuating unexpectedly during ablations and would get abnormally colder more quickly than expected.The balloon catheter was removed from the patient and a test freeze was performed.During the test freeze, it appeared that only one side of the balloon catheter was developing ice formation.It was suspected that a coolant jet may have been clogged.Despite the issues, the case was completed with cryo. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: an updated product analysis for the 2af284 balloon catheter with lot number 08185 was received.During functional testing, the balloon catheter reached a temperature colder than or equal to -50 degrees celsius (°c) during the last 120 seconds of the ablation as per specifications.The assembly of the injection tube was out of the specified tolerance limits (1.4 milimeter (mm), should be 2.5 +/- 0.5 mm).In conclusion, the balloon catheter additionally failed the return product inspection due to the coil distance from the proximal edge of the tip.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: 20451690
• Report Number: 2649622-2024-27497
• Device Sequence Number: 7007943
• Product Code: OAE
• UDI-Device Identifier: 00763000341480
• UDI-Public: 00763000341480
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2024

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: 04/18/2024
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 08185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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: Male