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 Problems Kinked (1339); Material Integrity Problem (2978)

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

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and balloon catheter, 2af284 with lot number 56485 were returned and analyzed.The data files showed at least thirty-six injections were performed with two catheters for the date of the event.System notice 50005 ¿the safety system has detected fluid in the catheter and stopped the injection¿ was seen in the failure files.Visual inspection of the catheter showed blood residue inside the balloon.The catheter failed the performance test due to the 50005-system notice.Dissection/ pressure testing showed a guide wire lumen was kinked/ twisted at 1.61 inches proximal from the tip and revealed a guide wire lumen breach at 1.61 inches from the tip.In conclusion, the reported issue was confirmed through testing and data analysis.The balloon catheter failed the inspection due to a guide wire lumen kink and breach.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.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.The balloon catheter subsequently tested out of specification per the manufacturer's investigation.

• 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: 7311247
• MDR Text Key: 101608717
• Report Number: 3002648230-2018-00133
• 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: 03/02/2018

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: 09/01/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 56485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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