MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR TRANSPOLAR PEN

Model Number MAX1

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

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 02/19/2019

Event Type  Death  

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 max1 device was not reported or able to be subsequently ascertained.The complaint could not be confirmed.

Event Description

It was reported that on (b)(6) 2019 a male patient underwent a bi-lateral mini-thoracotomy maze with laax.The surgeon performed the right pulmonary vein isolation via right mini-thoracotomy without incident and confirmed conduction block.Surgeon closed the right thoracotomy; the or staff repositioned the patient for the left-sided part of the procedure.At the same time surgeon noticed an unusual rhythm on the overhead monitors.The patient was cardioverted and administered amniodarone.The surgeon proceeded with the remainder of the maze procedure, made incision, while placing the soft-tissue retractor in the intercostal space, the circulating nurse announced that the patient had lost all vital signs.The patient was shocked numerous times to no avail and cpr was given.The patient was put on emergency cardiopulmonary perfusion and they were able to get a rhythm back.The maze procedure was not completed.The patient expired on (b)(6) 2019 and it was reported this was likely due to a myocardial infarction.This event is a procedure related complication, there was no reported device malfunction.

• Brand Name: ISOLATOR TRANSPOLAR PEN
• Type of Device: ISOLATOR TRANSPOLAR 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: 8437317
• MDR Text Key: 139352247
• Report Number: 3011706110-2019-00012
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061593
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAX1
• Device Catalogue Number: A000163
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2019
• 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, MID1, MAX5, ORLAB
• Patient Outcome(s): Death