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 Great Vessel Perforation (2152)

Event Date 09/27/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, a (b)(6) male patient underwent a (b)(6) procedure with left sided maze and left (b)(6) ligation.During (b)(6) the tissue was injured causing bleeding that required a suture to repair.Post procedure the patient was in stable condition.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the device was not reported or able to be subsequently ascertained.

• 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: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 12798969
• MDR Text Key: 284899021
• Report Number: 3011706110-2021-00048
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASU, ASB.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male