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 01/26/2018

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 shaft bent.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.(b)(6) 2018: incoming information indicated that this was a guide wire lumen kink.

Manufacturer Narrative

Product event summary: the data files and balloon catheter, 2af283 with lot number 17119 were returned and analyzed.The data files showed that at least four applications were performed with the returned catheter and thirteen applications were performed with a different catheter without any issue on the date of the event.Visual inspection of the balloon catheter showed that the shaft was kinked distal the strain relief.The kink might have occurred post procedure during shipment.The catheter failed the performance testing due to balloon oval shape during inflation.The push button was not retracting during inflation making the guide wire lumen to buckle inside the balloon.Dissection showed a guide wire lumen kink distal the relief strain.The kink could not happen while the guide wire or mapping catheter was inside.Further optical investigation showed the push button movement is restrictive due to presence of flash defect.In conclusion, the reported issue was confirmed through testing.The balloon catheter failed the inspection due to the guide wire lumen buckle inside the balloon and the stuck push button.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: product event summary: the data files and balloon catheter, 2af283 with lot number 17119 were returned and analyzed.The data files showed that at least four applications were performed with the returned catheter and thirteen applications were performed with a different catheter without any issue on the date of the event.Visual inspection of the balloon catheter showed that the shaft was kinked distal the strain relief.The kink might have occurred post procedure during shipment.The catheter failed the performance testing due to balloon oval shape during inflation.The push button was not retracting during inflation making the guide wire lumen to buckle inside the balloon.Dissection showed a guide wire lumen kink distal the relief strain.The kink could not happen while the guide wire or mapping catheter was inside.Additionally, the guide wire lumen was not kinked at the balloon segment.Further optical investigation showed the push button movement is restrictive due to presence of flash defect.In conclusion, the reported issue was confirmed through testing.The balloon catheter failed the inspection due to the guide wire lumen buckle inside the balloon and the stuck push button.However, a guide wire lumen kink was not reproduced through testing.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: 7252120
• MDR Text Key: 99888148
• Report Number: 3002648230-2018-00079
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2018

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: 05/25/2019
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 17119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 02/23/2018; 04/06/2018
• Supplement Dates FDA Received: 03/21/2018; 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2017
• 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
• Patient Weight: 85