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 Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the data files and balloon catheter, 2af284 with lot number 56619, were returned and analyzed.The data files showed that 4 applications were performed with the returned balloon catheter and another 4 applications with an unreturned catheter on the date of the event.System notice (b)(4) ¿leak detection¿ was observed multiple times.Visual inspection of the balloon catheter showed the balloon was pierced since there was blood inside.The performance test was not conducted due to previous damage.Pressure test and dissection revealed double balloon breach.In conclusion, the balloon catheter failed the returned product inspection due to a double balloon 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® 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: 8656013
• Report Number: 3002648230-2019-00408
• Device Sequence Number: 1832214
• Product Code: OAE
• UDI-Device Identifier: 00643169939318
• UDI-Public: 00643169939318
• 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): 05/30/2019

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: 12/11/2019
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 56619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1