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 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and balloon catheter, 2af284 with lot number 35135, were returned and analyzed.The data files showed at least thirteen applications were performed with this catheter.Also, the bin files confirmed system notice 50032 ¿the safety system has detected a compromised outer vacuum.¿ visual inspection of the balloon catheter showed the catheter was intact with no apparent issue.The performance test was not performed due to persistent system notice (b)(4).Dissection/ pressure testing revealed a leak in the inner balloon at the distal attachment with the catheter tip.Also, dissection showed the guide wire lumen kinked at 1.32 inches proximal from the tip.In conclusion, the balloon catheter failed the returned product inspection due to the inner balloon leak and the 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, a system notice was received indicating that the safety system detected a compromised outer vacuum.The balloon catheter was replaced with resolve, and 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: 7397557
• MDR Text Key: 104435475
• Report Number: 3002648230-2018-00199
• 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: 10/26/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 35135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2017
• 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
• Patient Age: 66 YR