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

Model Number	AFAPRO28
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	02/25/2020
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, the mapping catheter was unable to pass through the balloon catheter and resistance was felt.A kink was observed in the balloon catheter.The balloon catheter was replaced.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 data files and balloon catheter, afapro28 with lot number 22263, were returned and analyzed.The data files showed at least two applications were performed with the returned balloon catheter on the date of the event without any issue.Additionally, six applications were performed with a different balloon catheter without any issue on the date of the event.The data files confirmed multiple system notice 50005 ¿leak detection¿ on the date of the event.Visual inspection of the balloon catheter showed that the product was intact with no apparent issues.The catheter failed the performance test upon connecting to the console due to system notice 50005.The dissection/pressure test showed a guide wire lumen kink and twist inside the balloons at 1.1 inches from the tip of the catheter.Pressure test showed a breach at the same point of the guide wire lumen kink.Further analysis also revealed the guide wire lumen had breached at tip connection also.In conclusion, 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.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ 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: 9830058
• Report Number: 3002648230-2020-00157
• Device Sequence Number: 2896249
• Product Code: OAE
• UDI-Device Identifier: 00763000088637
• UDI-Public: 00763000088637
• 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): 04/05/2020

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 Expiration Date: 12/04/2020
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 22263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1