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

Model Number 2AF283

Device Problem Protective Measures Problem (3015)

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

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the 2af283 balloon catheter with lot 04363 was returned and analyzed.Visual inspection was performed, and a breach was observed on the guide wire lumen and the thermocouple wire was broken/detached at the balloon segment.During external visual inspection of the balloon, shaft, and handle segments no anomalies were identified.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for 11 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50005, "indicating that the safety system detected fluid in the catheter and stopped the injection." electrical testing was performed using an automatic electrical tester (aet).Test 1 pin was found to be out of specification; the value should be 190 ohms.The measured value of impedance was 261 ohms and failed the test.Test 5 - pin was found to be out of specification.The value should be 1 mohms.The measured value of impedance was 0.184 ohms and failed the test.Test 6 - pin was found to be out of specification.The value should be 1 mohms.The measured value of impedance was 0.041o hms and failed the test.During pressure testing and dissection of the balloon segment, a broken thermocouple was observed.During inspection and pressure testing of the shaft segment, a guide wire lumen kink and breach were observed at two locations, 1.5 inches and 3.25 inches proximal to the catheter tip.In conclusion, the balloon catheter failed the returned product inspection due to a guide wire lumen kink and breach, and broken thermocouple.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, after several successful ablations the physician decided to disconnect the electrical umbilical cable and coaxial umbilical cable "to tidy them up." after the cables were reconnected, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection. the cables were reconnected again without resolution.Both the electrical umbilical cable and coaxial umbilical cable were replaced, and then the console was restarted, however the system notice persisted.The balloon catheter was replaced, and a system notice was received indicating that there was a problem with the refrigerant port.The console was turned off for 10 minutes which resolved the system notices.The case was continued and on the second application a system notice was received indicating that the refrigerant delivery path was obstructed.The system notice persisted and the physician elected to abort the procedure. no patient complications have been reported as a result of this event.

• 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: 18048427
• MDR Text Key: 327081920
• Report Number: 2649622-2023-30308
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial
• Report Date: 11/01/2023

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 Expiration Date: 04/21/2024
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 04363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• 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