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	Device Contamination with Body Fluid (2317); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id: 203cx, product type: coaxial umbilical cable.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, a system notice was received indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled.The case continued and then a system notice was received indicating that the system detected a software error and stopped the injection.It was also reported that there was blood in the connection between the coaxial umbilical cable and balloon catheter.The balloon catheter and coaxial umbilical cable were 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: the patient data files and the 2af284 balloon catheter with lot number 12005 were returned and analyzed.The patient file showed one application was performed using catheter number one identified as a 2af284 balloon catheter with lot number 12005 and that eleven applications were performed using catheter number two identified as a 2af284 balloon catheter with lot number 11914.The patient file showed system notice 50008 (the system has detected a software error and stopped the injection) during inflation at application number two.The failure file was not received.The balloon catheter was visually inspected and functionally tested.External visual inspection of the balloon, shaft, and handle segments was performed.External visual inspection of the balloon segment showed blood inside the balloon.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for one application on the reported event date.During functional testing, the console terminated the application and triggered system notice 50005 (a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection).Pressure testing and inspection of sub-components of the balloon, handle, and shaft segments was performed.Pressurizing of the outer balloon identified the outer balloon distal bond was leaking and detached from the shaft.During inspection of the handle segment, blood was observed inside handle.In conclusion, the reported issue of "visible blood" and system notice 50008 were confirmed through testing and the balloon catheter failed the returned product inspection due to outer balloon distal bond detachment.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: 19657515
• Report Number: 2649622-2024-17478
• Device Sequence Number: 12418193
• Product Code: OAE
• UDI-Device Identifier: 00763000431532
• UDI-Public: 00763000431532
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 08/02/2024

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: 09/07/2024
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 12005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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: Unknown