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

Model Number AFAPRO28

Device Problems Compatibility Problem (2960); Material Integrity Problem (2978); Material Twisted/Bent (2981); Protective Measures Problem (3015)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and afapro28 balloon catheter with lot number 09928 were received and analyzed.The patient data file returned showed 15 applications were performed on event date.Applications one to seven were performed using afapro28 balloon catheter with lot number 9928.No system notices were triggered during these applications.Applications eight to 15 were performed using afapro28 balloon catheter with lot number 9839.No system notices were triggered during these applications.Based on the returned failure file, the following error message were recorded on the reported event date multiple times: 50005 "the safety system detected fluid in the catheter and stopped the injection" and 50006 "the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled." the external visual inspection of the balloon segment showed blood/fluid inside the balloon.During functional testing, the console terminated the application and triggered system notice 50005.Unable to insert the mapping catheter into the balloon catheter and the compatibility issue was confirmed.Dissection and further inspection identified a guide wire lumen kink inside the balloon segment.During inspection and pressure testing of the shaft segment, a guide wire lumen kink and breach was observed 0.8 inches proximal to the catheter tip.In conclusion, the system notice 50005 was confirmed through data analysis and an additional system notice 50006 was received during data analysis.The balloon catheter failed return inspection due to a guide wire lumen kink and breach.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 on the last ablation, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.It was noted there were issues retracting the catheter through the mapping catheter.After the catheter and mapping catheter were removed from the patient, it was observed that the mapping catheter had multiple kinks.Both the catheter and mapping catheter were replaced which resolved the issue. the case was completed with cryo.The data file were reviewed and confirmed the system notice.The console appeared to be controlling pressure and flow in the expected ranges. no patient complications have been reported as a result of this event.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ 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: 18182236
• MDR Text Key: 328673458
• Report Number: 2649622-2023-32880
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00763000341503
• UDI-Public: 00763000341503
• 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: 11/21/2023

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
• Device Operator: Health Professional
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 09928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2023
• 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: 2ACH20 MAPPING CATHETER