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

Model Number EMR2

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

Patient Problems Stroke/CVA (1770); Death (1802); Perforation (2001); Pneumonia (2011)

Event Date 12/05/2017

Event Type  Death  

Manufacturer Narrative

Case (b)(4): the device was returned for evaluation on (b)(6) 2017.The device evaluation indicated that the device met all specifications.There was no device malfunction reported during the procedure.

Event Description

On (b)(6) 2017, a (b)(6) male patient received a totally thoracoscopic vats/maze procedure using an ablation system with an isolator synergy clamp (emr2).The patient was heparinized for the procedure.During the procedure, the surgeon successfully applied the clamp around the right pulmonary veins and repositioned the clamp after each lesion.After the sixth (6) lesion was created, the clamp was released and there was visible bleeding.The tissue was perforated; the hole was on the anterior side of the right pulmonary vein.The surgical team quickly converted the procedure to a sternotomy, controlled the bleeding, and proceeded with the surgery as an on-pump assist without arresting the heart.The surgeon completed the lesion set and the procedure was prolonged for two hours.As of (b)(6) 2017, the patient was in stable condition.There was no reported device malfunction with this procedure.

Manufacturer Narrative

(b)(4): patient status update provided 1/8/2018, reported as patient death; date of patient death (b)(6) 2017.Additionally, cobra fusion, max5, mlp1, ach2 were identified as concomitant devices.No further information provided.

Event Description

On (b)(6) 2017, the patient had a stroke.The patient then developed pneumonia, had other unspecified complications and died (b)(6) 2017.

• 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: anupam bedi
• MDR Report Key: 7163384
• MDR Text Key: 96341813
• Report Number: 3011706110-2018-00112
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: EMR2
• Device Catalogue Number: A000452
• Device Lot Number: 77081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2017
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 148