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

Model Number 2AF283

Device Problems Loss of or Failure to Bond (1068); Protective Measures Problem (3015)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the 2af283 balloon catheter with lot number 04921 was returned and analyzed.Visual inspection was performed, and a bond detachment was observed at outer balloon proximal bond.External visual inspection of the balloon segment showed blood/fluid inside the balloon.The catheter smart chip data was reviewed.Data indicated the catheter was used for 27 applications.However, the catheter usage date recorded on the smart chip on (b)(6) 2024 did not correspond to the event date.During functional testing, the console terminated the application and triggered system notice 50005, "indicating 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 identified the outer balloon proximal bond was leaking and detached from the shaft.In conclusion, the balloon catheter failed the returned pr duct inspection due to an outer balloon proximal bond detachment.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 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 balloon catheter was removed under fluoroscopy "without any strain." the coaxial umbilical cable was replaced without resolution of the issue. it is unknown if the balloon catheter was replaced.The case was completed with cryo. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The reported issue 50006 "the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled" was not observed in the log/data/multimedia files.No patient or failure file were not received.In conclusion, the reported system notice 50006 "the safety system has detected blood in the cath handle, stopped the injection and disabled the vacuum" was not confirmed through data analysis.Updated e2.Hcp?: updated e3.Occupation: 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: 18862207
• MDR Text Key: 337206518
• Report Number: 2649622-2024-06610
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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
• Device Operator: Health Professional
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 04921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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