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 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device and data files were returned and analyzed.Data files showed 13 applications were performed with the catheter without any issues or system notices on the date of event.Also, 9 applications were performed with another catheter without any issues or system notices on the date of event.Visual inspection of the catheter showed no apparent issue.Smart chip verification showed that the catheter was used for 13 injections.Performance testing did not show any system notice.The catheter failed the deflection test due to deflection system clicking and a hard deflection.A dissection revealed both pull wires had derailed from the pulley inside the handle.Also, the guide wire lumen kink 1.4995 inches from the tip of the catheter.The catheter failed the performance test due a kink on guide wire lumen.The reported steerability was confirmed through testing but not confirmed through the data analysis.The catheter failed the returned product inspection due to a pull wire derailed from the pulley inside the handle and guide wire lumen kink.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 end of the balloon catheter looked bent, which appeared to be a broken pull wire.The balloon catheter was replaced and the case was completed with cryo.No patient complications have been reported as a result of this event.The device 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: 7635676
• MDR Text Key: 112558751
• Report Number: 3002648230-2018-00425
• 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: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 21521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• 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