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 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device and data files were returned and analyzed.Data files showed that 2 applications were performed with the balloon catheter on the date of the event.Both applications were short inflations.Also, 9 applications were performed with another balloon catheter with no issues.Visual inspection of the catheter showed that the device was intact with no apparent issues.No system notice was triggered during the functional test.A dissection showed a guide wire lumen kink 1.04 inches from the tip inside the balloons.Pressure testing did not show leaks.In conclusion, the reported kink issue was confirmed through testing.The catheter failed the return inspection due to a guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that prior to a cryo ablation procedure, the shaft of the balloon catheter was bent and unable to be straightened.The balloon catheter was replaced with resolve.The case was completed with cryo.The catheter was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

• 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: 7387369
• MDR Text Key: 104159011
• Report Number: 3002648230-2018-00192
• Device Sequence Number: 1
• Product Code: OAE
• 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: 03/30/2018

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: 09/27/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 88614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2017
• 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