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

Model Number OSL2

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

Patient Problem Perforation (2001)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was returned for evaluation and visually and functionally tested.Upon evaluation, device met all criteria and functioned normally.The complaint could not be confirmed.

Event Description

On (b)(6) 2017, a female patient received an on pump, concomitant mvr/maze procedure with laa management, using an atricure synergy ablation system.During the procedure, the surgeon created lesions using an isolator synergy clamp, standard jaw (osl2) for pvi and then a max1 isolator transpolar pen for epicardial roof and floor lesions with no pv dissection.The pvi lesions were created with two applications of the clamp, including a set of vertical lesions.The laa was removed and sewn shut; the surgeon did not indicate whether this was before or after the ablation.When the patient had been taken off-pump and the surgeon was ready to close the chest, bleeding was noted between the ablation lines near the laa and left pv.The patient was placed back on pump and a suture was applied to stop the bleeding which prolonged the procedure.The mvr, the maze and the laa removal were completed prior to the complication.The patient was doing well as of (b)(6) 2017.No device malfunction or other complications were reported.

• 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: 6926186
• MDR Text Key: 88944902
• Report Number: 3011706110-2017-00088
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D152172
• 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: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: OSL2
• Device Catalogue Number: A000432
• Device Lot Number: 75112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2017
• 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): Required Intervention
• Patient Weight: 82