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

Model Number 2AF234

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC INC.; 710 medtronic parkway; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC INC.; 710 medtronic parkway; minneapolis MN 55432
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7898257
• MDR Text Key: 121026734
• Report Number: 3002648230-2018-00674
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00643169504837
• UDI-Public: 00643169504837
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 2AF234
• Device Catalogue Number: 2AF234
• Device Lot Number: 06498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 10/17/2018
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 58