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 12/01/2017

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, it was noted that the inner lumen kinked in the balloon catheter.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product summary analysis: data files were returned and analyzed.Data files showed that eleven injections were performed with the balloon catheter on the day of the event.Also, a system notice was received indicating that the safety system detected a compromised outer vacuum on application two.In conclusion, the reported lumen kink issue was not confirmed through the data analysis.Analysis on the return product is in progress.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the balloon catheter, with lot number 88621 was returned and analyzed.Visual inspection of the catheter showed it was intact with no apparent issue.Smart chip verification showed that the catheter was not used.Performance test did not show any system notice.Dissection showed that the guide wire lumen kinked on 1.452 inches from the tip of the catheter.In conclusion, the reported issue was confirmed through testing.The balloon catheter failed the return product inspection due to the guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.

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: 7234909
• MDR Text Key: 98986678
• Report Number: 3002648230-2018-00057
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/19/2018

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: 09/25/2019
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 88621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/01/2018
• Supplement Dates Manufacturer Received: 02/02/2018; 02/06/2018; 03/19/2018
• Supplement Dates FDA Received: 02/02/2018; 03/02/2018; 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2017
• 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