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 Leak/Splash (1354); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

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

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported that during a cryo ablation procedure, the temperatures dropped faster than expected and the maximum flow was reached earlier than expected; the pressures and flow were in the expected range.It was further reported that frost was noted on the coaxial umbilical cable where it was connected to the balloon catheter.The physician elected to abort the procedure, and the patient was under general anesthesia. no further patient complications have been reported as a result of this event.

Event Description

It was later reported that while all four pulmonary veins were isolated, more ablations that were planned to be performed were not performed.

Manufacturer Narrative

Continuation of d10: product id: 203cxc, product type: coaxial umbilical cable product event summary: the data files and the 2af284 balloon catheter with lot number 10146 were returned and analyzed.The data files showed that 11 applications were performed using the 2af284 balloon catheter with lot number 10146 on the reported date of the event.The console output data (pressure, preset pressure, and flow) showed unexpected pressure profile during ablation at all applications.The console output data also showed that pressure was tracking preset pressure and flow readings were as expected; however, the temperature profile was not as expected during ablation at all applications.The console output data also showed unexpected flow profiles during ablation at all applications.External visual inspection of the balloon, shaft, and handle segments revealed no identified anomalies.The catheter smart chip data was downloaded and reviewed.The data indicated the catheter was used for 11 applications on the reported event date.During functional testing, frost was observed on the catheter shaft.No thresholds were exceeded and no console system notices were generated.The inflation, ablation, and thawing phases were completed.The coaxial port was detached from the handle and was pressurized from the injection tube at the coaxial port while the free side of injection tube was blocked at the other side.Pressure testing showed bubbles coming out from the coaxial port.A leak path at the bonding location of the injection tube and coaxial connector was identified.The decision to abort the procedure without use of alternate therapy was based on the medical judgement of the physician.In conclusion, aborted under general anesthesia cannot be assessed through data analysis.The balloon catheter failed the returned product analysis due to frost on the catheter shaft, a leak path observed from the injection tube through the coaxial connector adhesive, and unexpected pressure, temperature, and flow profiles during ablation at all applications.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.

• 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: 18305941
• MDR Text Key: 330220592
• Report Number: 2649622-2023-35076
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00763000341480
• UDI-Public: 00763000341480
• 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,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• 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: 10146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• 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
• Treatment: SEE H10...
• Patient Outcome(s): Other
• Patient Sex: Male