MAUDE Adverse Event Report: MEDTRONIC INC. ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	2AF234
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that post cryo ablation procedure, the patient had atypical chest pain for a few days, with mild shortness of breath.Oral medication was administered and the patient's hospitalization was extended.The case was already completed with cryo.It was noted that the patient's symptoms then resolved.The patient was part of the (b)(6) study.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
It was reported that post cryo ablation procedure, the patient had atypical chest pain for a few days, with mild shortness of breath.The catheter 2af283/ 06498 was not returned for investigation.In conclusion, this is a case related to a clinical adverse event (chest pain).There is no indication of relation of adverse event to the performance and malfunction of the product.The catheter was not returned for investigation.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): MEDTRONIC INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 7898257
• Report Number: 3002648230-2018-00674
• Device Sequence Number: 16185091
• Product Code: OAE
• UDI-Device Identifier: 00643169504837
• UDI-Public: 00643169504837
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P100010/S015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2AF234
• Device Catalogue Number: 2AF234
• Device Lot Number: 06498
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 58