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 Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The data files and balloon catheter afapro28 with lot number 15741 were returned and analyzed.The files showed at least 19 applications were performed with the catheter and system notice 50005 ¿the safety system has detected fluid in the catheter and stopped the injection¿ and system notice 50006 ¿the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled¿ were triggered on the date of the event.Smart chip verification indicated the catheter was used for 19 injections.Performance test failed due to system notice 50005 ¿the safety system has detected fluid in the catheter and stopped the injection¿ after connecting the catheter to the console.Visual inspection of the balloon catheter showed dried balloon inside inner balloon.A pressure test revealed a leak through the guide wire lumen, the balloons integrity was intact; no breach was observed.Visual inspection under microscope revealed a crack on the guide wire lumen at the attachment of the tip.In conclusion, the balloon catheter failed the returned product inspection due to the guide wire lumen leak at the tip attachment.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.
Additional Manufacturer Narrative
Upon further inspection of the balloon catheter, a crack on the guide wire lumen at the attachment of the tip was noted.The balloon catheter failed the inspection due to guide wire lumen breach at the connection with the tip.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: 9880105
• Report Number: 3002648230-2020-00174
• Device Sequence Number: 3041097
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 09/19/2020
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 15741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1