MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE SYNERGY ABLATION SYSTEM

Model Number OLL2

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

Patient Problem Atrial Perforation (2511)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was evaluated on 2/28/2017.The device evaluation indicated that the device met all specifications and functioned normally.There was no reported device malfunction.

Event Description

On (b)(6) 2018, a (b)(6) male patient received an on-pump, tricuspid valve replacement via sternotomy including box lesion set ablation using an atricure synergy ablation system with oll2 clamp.The patient was heparinized for the procedure.It was reported that the patient was malnourished and appeared extremely small.During the procedure, the surgeon performed some manual digital dissection of the left pulmonary veins and placed the clamp on the left side.After a lapse of 10-15 minutes with no mention of damage or bleeding, the surgeon performed cryoablation with a cryoice cryoablation probe (cryo2) for the roof and floor line connecting lesions with two minutes of freeze time.The surgeon performed additional digital dissection to gain access to the floor line.After defrosting normally, the probe was removed from the chest.At that time, a hole was discovered in the left atrium near the base of the left atrial appendage.The surgeon sutured the perforation indicating that the hole was most likely burned into the tissue due to the patient¿s decreased protein content.The surgeon decided not to place a clip on the laa.There was no reported transfusion required and no reported device malfunction.As of 2/13/2018, there was no reported negative outcomes per the charge nurse.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ATRICURE SYNERGY ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: anupam bedi
• MDR Report Key: 7328834
• MDR Text Key: 102072498
• Report Number: 3011706110-2018-00135
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 79867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2018
• 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
• Treatment: CRYO2
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR