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	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the balloon catheter 2af284, with lot number 35721, and the data files were returned and analyzed.The data files showed twenty-eight applications were performed with the returned catheter.Non-returned balloon catheter 2af284 with lot number 31166 was used for ten applications.The files showed system notice 50005, indicating that the safety system detected fluid in the catheter and stopped the injection, was received.Visual inspection of the returned balloon catheter showed the device was intact.The balloon catheter failed the performance test due to the triggering of system notice, 50005, stating the safety system detected fluid in the catheter and stopped the injection.The dissection test showed traces of blood inside the handle.The pressure test revealed a guide wire lumen breach and kink 1.45 inches from the tip.In conclusion, the balloon catheter failed the return product inspection due to the guide wire lumen breach and kink.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
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: 8885357
• Report Number: 3002648230-2019-00580
• Device Sequence Number: 2447772
• 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): 08/12/2019

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: 04/02/2020
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 35721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1