MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	2AF284
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryo ablation procedure, after balloon catheter set up, air aspiration was unsuccessful as air was introduced continuously.The sheath was replaced without resolve.Finally, the balloon catheter was replaced to resolve the air ingress issue.The case was completed with cryo.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the balloon catheter was returned and analyzed.Visual inspection of reported balloon catheter 2af284 lot number 29657 showed the device was intact with no apparent issues.Smart chip verification showed that the catheter was used for three applications.The reported balloon catheter passed both performance and electrical integrity tests as per specifications.In conclusion, the reported air ingress issue on the balloon catheter was not confirmed through product functional testing.The reported balloon catheter passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Common Device Name: 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
• MDR Report Key: 8043685
• Report Number: 3002648230-2018-00787
• Device Sequence Number: 19228776
• Product Code: OAE
• UDI-Device Identifier: 00643169753693
• UDI-Public: 00643169753693
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100010/S015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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
• Operator of Device: Health Professional
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 29657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1