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

Model Number EMR2

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

Case-(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 emr2 was not reported or able to be ascertained.

Event Description

It was reported that on (b)(6) 2021, a (b)(6) female underwent an off-pump inappropriate sinus tachycardia (ist) procedure.When removing the emr the inferior vena cava and right atrium were injured.Patient required a sternotomy and was placed on cardiopulmonary pump bypass to repair the tear.Patient is stable and recovering.There was no device malfunction and this event was the result of a procedural complication.

• 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: 11321029
• MDR Text Key: 231585062
• Report Number: 3011706110-2021-00006
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2021

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 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: 01/14/2021
• Initial Date FDA Received: 02/12/2021
• 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): Life Threatening
• Patient Age: 51 YR