MAUDE Adverse Event Report: ATRICURE, INC. MULTIFUNCTIONAL LINEAR PEN

Model Number MLP1

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

Patient Problem Cardiac Perforation (2513)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4) the mlp1 lot number 77591 was returned for evaluation and was visually and functionally tested.The complaint could not be confirmed, device passed all inspection criteria and functioned normally.The device met specifications.There was no reported device malfunction.

Event Description

It was reported that on (b)(6) 2018 a (b)(6) female underwent a tt maze/left atrial appendage management procedure.A mlp1 device was used for inferior vena cava lesion line and after one burn on the right atrium, upon pulling the mlp1 device away, a hole was created on the atrium.The surgeon used several types of topical anticoagulants including surgiflo, surgicel, and nu-knit to stop bleeding.The surgeon eventually closed the hole by tacking the patient¿s own pericardium to the heart wall with several prolene sutures thoracoscopically.No larger incision was needed to repair the perforation.Blood loss necessitated a blood transfusion of two units during the perforation repair.During the repair around 40 mg of protamine was given to reverse anticoagulation.Post successful repair, procedure then continued as planned with 5,000 units of heparin given, planned ablation was completed along with placement of a clip.Post-op status of the patient was stable, discharged on (b)(6) 2018.This event is a procedure related complication.There was no reported device malfunction.

• Brand Name: MULTIFUNCTIONAL LINEAR PEN
• Type of Device: MULTIFUNCTIONAL LINEAR PEN
• 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 ; 5137554563
• MDR Report Key: 8084249
• MDR Text Key: 127619658
• Report Number: 3011706110-2018-00219
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130521
• 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: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/01/2020
• Device Model Number: MLP1
• Device Catalogue Number: A000318
• Device Lot Number: 77591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• 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
• Treatment: COBRA FUSION, ATRICLIP
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 68 YR