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 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the balloon catheter tip appeared to be bent.Additionally, the balloon was r e-inflated a few times, and it appeared that the push button was still in a ¿stretched¿ position.The balloon catheter was replaced with the same lot and the second balloon catheter also appeared to be bent.A third balloon catheter was used of a different lot with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device and data files were returned and analyzed.Data files showed that 4 applications were performed with the balloon catheter on the date of the event with no system notice and any issue.Also, 1 application was performed with a second balloon catheter on the date of the event with no system notice or any issue.16 applications were performed with a third balloon catheter on the date of the event and a system notice indicating that the refrigerant level was too low (#50013) was triggered.Visual inspection of the catheter showed that the device was intact with no apparent issue.Verification of the smart chip file showed that this catheter was used for 1 injections.The catheter passed the performance test; electrical integrity and impedance were also within specification.A dissection showed a guide wire lumen kink 1.4820 inches from the tip of the catheter.The catheter failed the performance test due to kink on guide wire lumen.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: 7506838
• MDR Text Key: 108153734
• Report Number: 3002648230-2018-00308
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

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: 12/06/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 95138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/18/2018
• Date Device Manufactured: 12/06/2017
• 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