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 Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed at least two applications were performed with catheter 2af284/83558 on the date of the event without any system notices.Both applications were non-sustained (could be stopped by physician).Failure file confirmed system notice (# (b)(4)) was received indicating that the safety system detected fluid in the catheter and stopped the injection for the date of the event.Visual inspection of balloon catheter 2af284/83558 showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for two applications on the date of the event.The catheter failed the performance test due to system notice indicating that the safety system detected fluid in the catheter and stopped the injection.The dissection/pressure test showed a guide wire lumen kink inside the balloons at 1.4 inches from the tip of the catheter.Pressure test did show leaks from guide wire lumen breach.In conclusion, the reported issue (system notice # (b)(4)) was confirmed through testing.The balloon catheter failed the returned product inspection due to a guide wire lumen kink and breach.If information is provided in the future, a supplemental report will be issued.

Event Description

The balloon 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: 7852128
• MDR Text Key: 119502465
• Report Number: 3002648230-2018-00621
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 02000013142941
• UDI-Public: 2000013142941
• Combination Product (y/n): N
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2019
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 83558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Date Manufacturer Received: 08/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2018
• 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