MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE ISOLATOR SYNERGY ENCOMPASS CLAMP AND GUIDESYSTEM

Model Number OLH

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

Patient Problem Cardiac Perforation (2513)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) the olh device was not returned for evaluation, but a device history review was obtained for lot number p1350b.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

It was reported that on (b)(6) 2021 an (b)(6)-year-old female patient underwent an aortic aneurysm with cardiac ablation procedure.While routing the olh clamp and guide, the surgeon encountered difficulty with inserting the device into the chest cavity.Once the clamp was in position around the left atrium, the surgeon noted a hole in the left atrium, removed the clamp, and resolved bleeding with stitch.Surgeon positioned clamp again after resolving the bleeding and successfully performed ablations.Patient was in normal sinus rhythm post-operatively.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ATRICURE ISOLATOR SYNERGY ENCOMPASS CLAMP AND GUIDESYSTEM
• Type of Device: ATRICURE ISOLATOR SYNERGY ENCOMPASS CLAMP AND GUIDESYSTEM
• 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: 12367131
• MDR Text Key: 268123211
• Report Number: 3011706110-2021-00038
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2021

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 Expiration Date: 04/01/2024
• Device Model Number: OLH
• Device Catalogue Number: A001143
• Device Lot Number: P1350B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 84 YR