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 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files confirmed system notice (#(b)(4)) indicating that the safety system detected a compromised outer vacuum at application number seven for catheter 2af284 / 78610-(b)(4) on the date of event.Bin files also showed at least sixteen applications were performed with this catheter.The data files showed at least ten applications were performed with catheter 2af284 / 24678-(b)(4) without any system notices on the date of event.Flow and pressure were lower than expected during several applications.Upon visual inspection of catheter 2af284 / 78610-(b)(4), results showed the device was not intact with kink on guide wire lumen.Smart chip verification indicated the catheter was used for sixteen injections.The catheter failed the performance due to the kink on the guide wire lumen.System notice #(b)(4) "outer vacuum compromised" could be related to an intermittent electrical signal from the auto-connection box or electrical umbilical cable.The auto-connection box for this case was not returned.In conclusion, the reported issues (#(b)(4), pressure, flow and hissing) has been not confirmed through testing but confirmed through the data analysis.The reported issues (#(b)(4), hissing) has been not confirmed through testing and through the data analysis.The catheter 2af284 / 78610-(b)(4) failed the returned product inspection due to 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 electrical umbilical cable was disconnected without resolve.The auto connection box and electrical umbilical cable were both replaced without resolve.The console was rebooted without resolve.The balloon catheter was also replaced without resolve.All connections were checked and the console was rebooted again without resolve, but the case was able to be continued.Later in the procedure, the balloon did not appear to be fully inflated.Additionally, pressure was not as expected.The case continued, and a hissing sound was observed from the balloon catheter.The coaxial umbilical cable was replaced without resolve.The case continued, and a system notice was received indicating that the safety system detected a compromised outer vacuum.The physician switched back to the original balloon catheter, and the case was able to be completed with cryo.A field service visit was recommended.No patient complications have been reported as a result of this event.(b)(6) 2018: the balloon catheter 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: 7266716
• MDR Text Key: 100125046
• Report Number: 3002648230-2018-00092
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2018

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: 06/30/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 78610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• 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