MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX

Model Number CDK-1413

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

Patient Problem Stroke/CVA (1770)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the surgeon that on (b)(6) 2021 an obese female patient with a pre-existing history of chronic obstructive pulmonary disease underwent a convergent procedure; no clip was placed due to patient anatomy.There were no procedure or device complications, and patient was discharged on (b)(6) 2021.The patient discontinued their own anticoagulation at home (against physician orders) and presented back to facility on (b)(6) 2021 where a mri and ct scan was performed which revealed multiple punctate infarcts (stroke).Physician believes the incident was related to the patient discontinuing their anticoagulation and not related to the procedure.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Type of Device: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• 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: 12456951
• MDR Text Key: 271332286
• Report Number: 3011706110-2021-00040
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193162
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK-1413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2021
• 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