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 Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the data files and afapro28 balloon catheter with lot 22265 were returned and analyzed.The data files showed at least one application was performed with the balloon catheter.The data files also confirmed multiple occurrences of system notice 50022; indicating a mechanical component error, 50024; indicating that there was a problem with the refrigerant port, and 50013; indicating that the refrigerant level was too low to continue on the date of the event.Visual inspection of the balloon catheter showed that the catheter was intact without any issues.Smart chip verification showed that the catheter was used for eight applications on date of event.The balloon catheter failed the performance test due to a guide wire lumen kink during inflation.Further visual investigation showed the push button movement was restricted due to the presence of a flash defect.The dissection/pressure test showed a guide wire lumen kink and breach inside the balloon segment.The guide wire lumen kink and push button friction might have caused the guide wire lumen to buckle inside the balloon.In conclusion, the balloon catheter failed the returned product inspection due to the guide wire lumen kink and breach.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
After a completed case, the balloon catheter subsequently tested out of specification per the manufacturer's investigation.

• 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: 9974304
• Report Number: 3002648230-2020-00228
• Device Sequence Number: 2784675
• Product Code: OAE
• UDI-Device Identifier: 00763000088637
• UDI-Public: 00763000088637
• 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): 04/17/2020

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: 12/10/2020
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 22265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2020
• Initial Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1