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 Codes	Material Integrity Problem (2978); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The data files and balloon catheter afapro28 with lot number 31696 were returned and analyzed.Data files showed at least 15 applications were performed with the returned balloon catheter without any issue on the date of the event.The file did not show any system notice on the event date.Smart chip verification indicated the catheter was used for 15 injections.The catheter failed the performance test due to system notice 50005 "the safety system detected fluid in the catheter and stopped the injection," right after connecting to the console.Visual inspection of the balloon catheter showed the catheter was stuck inside the sheath.The catheter was removed from the sheath by manual retraction (inflating and vacuum balloon when the push button is in the forward position).The guide wire lumen was kinked inside the balloon segment.Dissection and pressure tests showed leak at the guide wire lumen of the catheter at 32 mm from the tip and at the detachment from the tip.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: 9869761
• Report Number: 3002648230-2020-00170
• Device Sequence Number: 560774
• 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): 03/23/2020

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: 09/29/2020
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 31696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1