MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMP

Model Number EML2

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

Patient Problems Death (1802); Atrial Perforation (2511)

Event Date 08/20/2019

Event Type  Death  

Manufacturer Narrative

(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 eml2 device was not reported or able to be subsequently ascertained.

Event Description

It was reported on (b)(6) 2019 that (b)(6) year old female patient underwent a total thoracoscopic ablation procedure.The surgeon completed left pulmonary vein isolation and then completed the roof and floor lesions; with the mlp device.When the surgeon was removing the bipolar clamp from around the right pulmonary veins from a left sided approach where he experienced some difficulty and resulted in injury to the left atrium causing bleeding.A median sternotomy was performed, and the patient was placed on cardiopulmonary bypass.The injury to the left atrium was repaired and the left sided lesion set of the maze procedure was completed.A cryo2 probe was used to complete the left atrial lesion set.Post operatively the patient was successfully extubated.Patient condition deteriorated and she developed multiorgan failure and died on (b)(6) 2019.There was no reported device malfunction.This is a procedural complication.

• Brand Name: ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMP
• Type of Device: ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMP
• 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: 9081795
• MDR Text Key: 158980365
• Report Number: 3011706110-2019-00042
• 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: Physician
• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EML2
• Device Catalogue Number: A000467
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2019
• 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: CRYO2, MID1, MLP
• Patient Outcome(s): Death
• Patient Age: 80 YR