MAUDE Adverse Event Report: MPRI ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AF284

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2024

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 106a3 (5m0283); product type: 0628-console spare parts; implant date: n/a, explant date: n/a.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 Description

It was reported, that during a cryoablation procedure.The temperatures were lower than expected, and a full ablation was unable to be completed.The consumables were reconnected, the tank, coaxial umbilical cable and electrical umbilical cable were replaced.And the auto connection box was bypassed without resolution.The case was aborted, while the patient was under general anesthesia.The data files were later reviewed, and a system notice was received, indicating that the system detected a software error and stopped the injection.During a later, servicing of the console, the temperature and power supply voltage were calibrated.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.Two patient data files were received and recorded on the reported date of the event.The first patient data file showed ten applications were performed using the console with serial number (b)(6) and catheter number one identified as 2af284 with lot number 12372.The console's output data (pressure, preset pressure and flow) showed unexpected pressure and flow profiles during ablation at applications one, six, and nine with catheter 2af284 with lot number 12372.The patient data file also showed three applications were performed using the console with serial number (b)(6) and catheter number two identified as 2af284 with lot number 12362.The second patient data file showed 16 applications were performed using console with serial number (b)(6) and the catheter identified as 2af284 with lot number 11332.The second patient file also showed system notice 50008 (the system detected a software error and stopped the injection) during the sixth application with catheter identified as 2af284 with lot number 11332.The console output data (pressure, preset pressure and flow) showed unexpected pressure and flow profiles during ablation at applications one, three, four, eight, ten, eleven, thirteen, and fourteen with catheter identified as 2af284 with lot number 11332.The fluctuations of pressure and flow had a plausible impact on the ablation temperature.In conclusion, the 50008 was confirmed through data analysis and the temperature issues were plausible.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.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
• Type of Device: 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: 19169293
• MDR Text Key: 340899562
• Report Number: 2649622-2024-11253
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 12372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female