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

Model Number 2AF283

Device Problem Kinked (1339)

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

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Visual inspection of the catheter showed that the device was intact with no apparent issues.Smart chip verification indicated that the catheter was used for 13 injections.A dissection showed a guide wire lumen kink 1.36 inches from the tip of the catheter.Pressure testing did not show leaks and the catheter passed performance testing.In conclusion, the reported kinked balloon was confirmed through testing.The catheter failed 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 during a cryo ablation procedure, the balloon was observed to be kinked.The balloon catheter was replaced and 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.

Manufacturer Narrative

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 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: 7316502
• MDR Text Key: 101846309
• Report Number: 3002648230-2018-00137
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

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: 10/18/2019
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 27064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• 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