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 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and balloon catheter, 2af284 with lot number 74986 were returned and analyzed.Data files showed that three injections were performed with this balloon catheter without triggering any system notices.A different catheter had eight injections and produced an unrelated system notice # (b)(4) ¿the system has detected an electrical component failure¿.Visual inspection of the balloon catheter showed that a mapping catheter was stuck in the guide wire lumen and it could not be removed.The balloon catheter passed the performance test and electrical integrity as per specification; impedance was also within specification.Inflations were sustained for more than 2 minutes.The dissection/pressure test showed a guide wire lumen kink inside the balloons at 1.1 inches from the tip of the catheter.Dissection also showed dried saline inside the guide wire lumen.In conclusion, the balloon catheter failed the return product inspection due to a guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.

Event Description

The device was returned to the manufacturer, analyzed, and tested out of specification.

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: 7310981
• MDR Text Key: 101475361
• Report Number: 3002648230-2018-00132
• 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,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: 06/27/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 74986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2017
• 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