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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The balloon catheter, 2af284 with lot number 80379, was returned and analyzed.Visual inspection of the balloon catheter showed the catheter was intact without any issue.Smart chip verification indicated that the catheter was not used.Without reprogramming the catheter, it was connected to the console and no system notices were received; catheter was recognized.The catheter passed the insertion test with a test sheath.The balloon was advanced outside the sheath and aspiration/flushing was performed without any issue.During inflation the shape of the balloon was not spherical but oval and the push-button was not retracting as expected.X-ray imaging showed the guide wire lumen was kinked at the balloon segment.The outer diameter of the balloon proximal and distal bonding were within specification 0.156 and 0.153 inches respectively.The dissection/pressure test showed a guide wire lumen kink inside the balloons at 1.41 inches from the tip.In conclusion, the balloon catheter failed the returned product inspection due to a guide wire lumen kink.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® 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: 9255174
• Report Number: 3002648230-2019-00742
• Device Sequence Number: 19747925
• Product Code: OAE
• UDI-Device Identifier: 00643169976382
• UDI-Public: 00643169976382
• 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): 10/30/2019

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 Expiration Date: 04/23/2020
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 80379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1