MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SURGICAL ABLATION SYSTEM

Model Number EMR2

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

Patient Problem Cardiac Perforation (2513)

Event Date 10/05/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 a 72-year-old male patient underwent a totally thoracoscopic maze procedure.During dissection, an abrasion on the rspv was noticed.The emr2 ablation clamp was placed around the rpvs, and ablations were performed.After retracting the clamp, surgeon noticed bleeding.Surgical approach was converted to median sternotomy and patient placed on cardiopulmonary bypass.A perforation was located in the rspv and repaired.The procedure was completed.

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: ISOLATOR SURGICAL ABLATION SYSTEM
• Type of Device: ISOLATOR SURGICAL 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: 18065138
• MDR Text Key: 327280724
• Report Number: 3011706110-2023-00044
• 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: 11/03/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 11/03/2023
• 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
• Treatment: MID1, ENDOSCOPIC KITTNER, ENSEAL
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male