MAUDE Adverse Event Report: ATRICURE, INC. ENCOMPASS SYNERGY CLAMP (LONG)

Model Number OLH

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

Patient Problem Stroke/CVA (1770)

Event Date 01/31/2024

Event Type  Injury  

Event Description

A patient underwent coronary artery bypass graft and aortic valve repair/replacement surgery via median sternotomy with concomitant posterior wall and left atrial appendage to left superior pulmonary vein cardiac ablation using an olh clamp.Medical history included coronary artery disease and aortic calcification.Post-operatively, the patient had a stroke.No diagnostic information regarding stroke was provided.The patient recovered.While there is no evidence that the atricure device directly caused the stroke, contribution from the ablation procedure cannot be ruled out and so this event is being reported per part 803.There were no reported device malfunctions, and this 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: ENCOMPASS SYNERGY CLAMP (LONG)
• Type of Device: ENCOMPASS SYNERGY CLAMP (LONG)
• 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: 18821278
• MDR Text Key: 336736020
• Report Number: 3011706110-2024-00018
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OLH
• Device Catalogue Number: A0001143
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other