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 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device and data files were returned and analyzed.Data files showed a system notice indicating that the refrigerant level was too low to continue (#50013) on the date of the case.Visual inspection of the catheter showed that the od of the balloon proximal bonding was within specification 0.155¿.The balloon was misshaped and the push button of the catheter was in the back position.The push button retracted during insertion has been identified as the cause of the insertion difficulty.As it caused the balloon material to fold up in itself increasing the od and there was crack on the folding sleeve.The insertion difficulty was reproduced.Smart chip verification indicated the catheter was not used.Without reprogramming the catheter, it was connected to the console and no system notices were received.The catheter failed the performance test due to a system notice indicating that the balloon is deflated (#22406) which was triggered in less than 2 minutes.Also, the inflation was not sustained for 2 minutes.A dissection and pressure testing showed a leak through the luer connector adhesive to the push button.Also, a guide wire lumen kink was inside the balloons from the tip of the catheter.In conclusion, the reported af/fc compatibility and achieve broken issues were not confirmed through data analysis but were confirmed during testing.The catheter failed the product return inspection test due to a balloon material folding up caused by retraction of the push button.Also, the broken push button luer.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure, the balloon catheter could not be inserted into the sheath.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 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: 7612547
• MDR Text Key: 111443308
• Report Number: 3002648230-2018-00399
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2020
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 33894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• 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
• Treatment: 4FC12 SHEATH, 990063-20 CATHETER