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

Model Number EMR2

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

Patient Problem Pulmonary Valve Stenosis (2024)

Event Type  Injury  

Manufacturer Narrative

Case: (b)(4) the emr2 device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the emr2 device was not reported or able to be subsequently ascertained.

Event Description

On 10-mar-2021 during a literature search, atricure was made aware of an event from the casa-af (uk isrctn18250790).A patient underwent a thoracosopic surgical ablation (sa) procedure (procedure date unk).The procedure was using right-sided epicardial pulmonary vein (pv) isolation using the bipolar radiofrequency (rf) clamp.Linear epicardial ablation was also conducted.The procedure was completed.During follow-up, patient was symptomatic of pulmonary vein stenosis, which required pulmonary vein angioplasty.The issue was fully resolved and patient is recovering with no long term impact.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• 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: scott ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 11638025
• MDR Text Key: 244606912
• Report Number: 3011706110-2021-00013
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EMR2
• Device Catalogue Number: A000452
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention