MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE ST COAGULATION DEVICE

Model Number EPI-ST

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

Patient Problem Cardiac Tamponade (2226)

Event Date 10/22/2023

Event Type  Injury  

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 device was not reported or able to be subsequently ascertained.

Event Description

On 3-oct-2023, 64-year-old male patient underwent posterior wall ablation via sub-xiphoid approach with epi-st device.On (b)(6) 2023 (pod 19), patient presented to a different hospital with symptoms and diagnosed with cardiac tamponade.Patient underwent treatment consisting of pericardial window with drainage of 800ml of fluid.Patient's hemodynamics stabilized.Patient if recovering in icu.This is a procedural complication and there is no alleged device malfunction.

• Brand Name: EPI-SENSE ST COAGULATION DEVICE
• Type of Device: COAGULATION DEVICE
• 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: 18161872
• MDR Text Key: 328423894
• Report Number: 3011706110-2023-00049
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200002
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EPI-ST
• Device Catalogue Number: A001370
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• 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
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male