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

Model Number	AFAPRO28
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the returned balloon catheter with lot number 14270 and the data files were returned and analyzed.External visual inspection of the balloon catheter showed the a portion of the proximal bond of the outer balloon was detached.Verification of the smart chip file indicated the catheter was used for 18 injections on the date of the event.The catheter failed the performance test during the connection of the balloon catheter and the console due to triggering of system notice 50005 "the safety system has detected fluid in the catheter and stopped the injection." by opening the handle, the "y-block fitting" which is inside of the y-block, was filled with blood.There was blood throughout the handle which would eventually cause the system notice 50006 "the safety system has detected blood in the catheter handle, stopped the injection and disabled the vacuum" and 50005 "the safety system has detected fluid in the catheter and stopped the injection".Looking closely to the picture of the detached bond, there is a pathway in blood from the outer balloon to the laser hole.This would explain the blood found in the catheter.Furthermore, the missing bond from the picture may be inside of the sheath.The data files confirmed the 50006 system notice "the safety system has detected blood in the catheter handle, stopped the injection and disabled the vacuum.In conclusion, the balloon catheter failed the returned product inspection due to the detached outer balloon proximal bond.
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: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, 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: 12496041
• Report Number: 3002648230-2021-00438
• Device Sequence Number: 16993640
• Product Code: OAE
• UDI-Device Identifier: 00763000245436
• UDI-Public: 00763000245436
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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: 05/25/2022
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 14270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1