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 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient files showed at least thirteen injections were performed on the date of the event without any system notice triggered.The first four applications were performed with catheter 2af284/95135-30; the other nine applications were performed with catheter 2af284/95126-59.Based on the pt5 reading, during some of the applications the pt5 reading was lower than the lower pressure limit that can trigger system notice (#(b)(4)) indicating that the balloon was deflated during inflation.The data files are from console 106a3 / 5m0136.Visual inspection of catheter 2af284 / 95135-30 showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for four injections.The catheter failed the performance test due to a high base line flow; inflation was not sustaining 2 minutes and system notice (#(b)(4)) was received indicating that the balloon was deflated.Pressure test revealed a leak through the vacuum line at the proximal end attachment with the push button.Further dissection revealed a guide wire lumen kink/twist and a guide wire lumen leak at the extremity of the push button.The coaxial umbilical cable passed the performance test with a lab test catheter.In conclusion, the reported inflation issue has been confirmed through testing and data analysis.The balloon catheter failed the returned product inspection due to guide wire lumen kink/twist and a guide wire lumen leak at the extremity of the push button.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 balloon was deflated.The ¿ok¿ button was selected on the console without resolve.The coaxial umbilical cable was reconnected without resolve.The coaxial umbilical cable was replaced without resolve.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.On 2018-04-26: upon return and analysis, there was an out of specification finding on the balloon catheter.

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: 7484340
• MDR Text Key: 107346241
• Report Number: 3002648230-2018-00287
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

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: 12/07/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 95135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• 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: 70 YR