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	Material Integrity Problem (2978); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the 2af284 balloon catheter with lot number 08839 was returned and analyzed.Visual inspection was performed.No anomalies were identified during external visual inspection of the balloon, shaft, and handle segments.External visual inspection of the balloon segment showed blood/fluid inside the balloon.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for eight applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50007 "the safety system detected fluid in the console and the system in inoperable." during functional testing, the temperature readings were colder than normal and temperature spikes were noted.During inspection and pressure testing of the shaft segment, a guide wire lumen breach was observed one inch proximal to the catheter tip and the injection tube was located within inner balloon's neck.In conclusion, the temperature issue was confirmed and the balloon catheter failed the returned product inspection due to a guide wire lumen breach and the injection loop at the tip of the guide wire lumen was close to the balloon distal tip.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryo ablation procedure, the temperature readings were colder than normal and temperature spikes were noted.It was suspected that the thermocouple of the balloon catheter may have been bad.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
Product event summary: data files were received and analyzed.The patient data file showed eight applications were performed using 2af284 balloon catheter with lot number 08839.The patient data file showed six applications were performed using 2af284 balloon catheter with lot number 08184.The console output data (pressure, preset pressure, and flow) showed the pressure was tracking preset pressure and the flow readings were as expected.The temperature profile was unexpected using 2af284 balloon catheter with lot number 08839 during ablations at applications three, five and six.In conclusion, the temperature issues were confirmed though data analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the 2af284 balloon catheter with lot number 08839 was re-analyzed after secondary review.Visual inspection was performed.No anomalies were identified during external visual inspection of the balloon, shaft, and handle segments.External visual inspection of the balloon segment showed blood/fluid inside the balloon.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for eight applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50007 "the safety system detected fluid in the console and the system in inoperable." during inspection and pressure testing of the shaft segment, a guide wire lumen breach was observed one inch proximal to the catheter tip in conclusion, the temperature issue was not confirmed and the balloon catheter failed the returned product inspection due to a guide wire lumen breach.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: 18121508
• Report Number: 2649622-2023-31747
• Device Sequence Number: 15172185
• Product Code: OAE
• UDI-Device Identifier: 00763000341480
• UDI-Public: 00763000341480
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/04/2025

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: 04/22/2024
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 08839
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 11/13/2023; 03/06/2025
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/06/2023; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2023
• 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
• Patient Sex: Unknown