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

Model Number EML2

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

Patient Problem Great Vessel Perforation (2152)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) the eml2 atricure bipolar system was returned for evaluation and visually and functionally tested pursuant to regulation.The device met all criteria and functioned normally.The complaint could not be confirmed.

Event Description

On (b)(6) 2018, a (b)(6) female underwent a vats totally thorascopic maze procedure.The right-side ablations had been completed and while using the eml2 clamp on the left side ablation, bleeding was observed when the clamp opened after the first ablation.The procedure was then converted via sternotomy with the eml2 kept in place to minimize the bleeding through a small hole on superior/anterior aspect of left superior pulmonary vein.Once the procedure was converted, the bleeding was controlled with suture.The patient was fully heparinized before going on pump and was not reversed.The bleed did not necessitate a transfusion with the procedure being prolonged approximately 1 hour.Post procedure, the patient was doing good and was in sinus rhythm.

• 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: 7236631
• MDR Text Key: 98840672
• Report Number: 3011706110-2018-00124
• 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
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: EML2
• Device Catalogue Number: A000467
• Device Lot Number: 74405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR