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

Model Number 2AF284

Device Problem Kinked (1339)

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

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and balloon catheter 2af284, with lot number 44360 were returned and analyzed.The data files showed at least five not sustained applications were performed with this catheter on the date of the event.Visual inspection of the balloon catheter showed the device was intact with no apparent issues.Dissection showed a guide wire lumen kink at 1.4 inches from the tip inside the balloons.Pressure test did not show leaks.In conclusion, the balloon catheter failed the return product inspection due to the guide wire lumen kink found upon analysis.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 balloon shape was not as expected and did not fully inflate.The coaxial umbilical cable and electrical umbilical cable were replaced without resolve.The balloon catheter was then replaced with resolve.Later in the procedure, temperature was not as expected.The electrical umbilical cable and auto connection box were replaced without resolve.The case was completed with radiofrequency.No patient complications have been reported as a result of this event.The catheter was returned to the manufacturer, analyzed, and tested out of specification.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7395831
• MDR Text Key: 104542668
• Report Number: 3002648230-2018-00195
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00643169753693
• UDI-Public: 00643169753693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2018

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: 10/31/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 44360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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