MAUDE Adverse Event Report: MEDTRONIC, INC. ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AF283

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

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 guidewire lumen kinked.The balloon catheter was replaced with resolve.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 and balloon catheter, (b)(4) with lot number 90776, were returned an analyzed.The data files showed twelve applications which showed a system notice 50012, which indicates ¿the refrigerant delivery path is obstructed¿ was triggered on applications one and two.The first 4 applications were performed with balloon catheter (b)(4), with lot number 90776, and the last 8 applications were performed with balloon catheter (b)(4), with lot 90776.External visual inspection of the balloon catheter showed the device was intact with no apparent issues.Dissection of the balloon catheter showed a guide wire lumen kink 1.02 inches from the tip inside of the balloon.The pressure test did not show any leaks.In conclusion, the reported guide wire lumen kink was confirmed through product analysis but not confirmed through the data analysis.The balloon catheter failed the return product inspection due to the guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7861376
• MDR Text Key: 119797222
• Report Number: 3002648230-2018-00635
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 90776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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