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

Model Number MLP1

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

Patient Problems Stroke/CVA (1770); Fistula (1862)

Event Date 02/17/2023

Event Type  Death  

Manufacturer Narrative

(b)(4) the mlp1 device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number was not reported.There was no reported device malfunction.

Event Description

On (b)(6) 2022, a patient underwent an off-pump, heparinized video assisted thoracoscopic (vats) maze procedure with concomitant left atrial appendage exclusion (laae).The transesophageal echocardiography (tee) probe was not retracted during the ablation.3-4 weeks post-op, the patient collapsed and was transported to the emergency room.A ct confirmed an air embolic stroke.Patient underwent hyperbaric treatment, but neurological signs did not improve.The patient was taken to surgery, during which the physician observed a hole in the anterior esophagus with communication between the anterior esophagus and the pericardium.The hole was repaired, and the patient returned to the icu.Postoperatively, the patient did not recover from his stroke and ultimately expired.There was no reported device malfunction, and this event was the result of a procedural complication.

• 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 ; 5136448220
• MDR Report Key: 16480609
• MDR Text Key: 310635172
• Report Number: 3011706110-2023-00010
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192125
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MLP1
• Device Catalogue Number: A000318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• 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: EMR2, EML2, PRO235.
• Patient Outcome(s): Death