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 Codes	Material Integrity Problem (2978); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the data files and balloon catheter, 2af284 with lot number 71661 were returned and analyzed.The data files showed that at least 6 injections were performed with the returned balloon catheter on the date of the event with system notice (b)(4) ¿the safety system has detected fluid in the catheter and stopped the injection¿ triggered on one application.Also, 8 injections were performed with a different balloon catheter on the date of the event with no issue.Visual inspection of the returned balloon catheter showed traces of blood inside the balloons.The catheter failed the performance test due to system notice (b)(4) right after connecting to the console.Dissection and pressure tests showed a kink and leak at guide wire lumen in the balloon segment 1.01 inch from the tip.In conclusion, the balloon catheter failed the return 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 or Problem Description
It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.The balloon catheter was replaced without issue.The case was completed with cryo.No patient complications have been reported as a result of this event.The balloon catheter was returned to the manufacturer, analyzed, and tested out of specification.

• 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: 7981759
• Report Number: 3002648230-2018-00737
• Device Sequence Number: 11104840
• Product Code: OAE
• UDI-Device Identifier: 00643169753693
• UDI-Public: 00643169753693
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100010/S015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2018

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
• Operator of Device: Health Professional
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 71661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1