MAUDE Adverse Event Report: MPRI ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	2AF284
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a cryo ablation procedure, blood was visible in the coaxial/catheter connection.Blood was also noted in the coaxial port on the console, however, there was no blood in the blood bottle.The balloon catheter and coaxial umbilical cable were replaced.The case was completed with cryo.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER
• Common Device Name: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 9781757
• Report Number: 2649622-2020-04410
• Device Sequence Number: 13602225
• Product Code: OAE
• UDI-Device Identifier: 00643169878365
• UDI-Public: 00643169878365
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2020

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: 11/19/2020
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 00307
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/03/2020; 03/03/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/03/2020; 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1