MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE BIPOLAR SYSTEM

Model Number EMR2

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

Patient Problem Cardiac Perforation (2513)

Event Date 09/28/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a patient underwent video-assisted thoracic ablation procedure.During procedure, as physician was advancing the emr2 device patient sustained injury to the transverse sinus.Patient was hemodynamically unstable, so procedure was converted to a sternotomy with cardiopulmonary bypass.Physician sutured the injured area, and the procedure was completed.Patient left the operating room in stable condition.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Manufacturer Narrative

(b)(4).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 BIPOLAR SYSTEM
• Type of Device: ATRICURE BIPOLAR 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: 17975911
• MDR Text Key: 326165280
• Report Number: 3011706110-2023-00042
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110117
• 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: 10/20/2023

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 Model Number: EMR2
• Device Catalogue Number: A000452
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/20/2023
• 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): Required Intervention; Life Threatening