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 Transient Ischemic Attack (2109)

Event Date 01/09/2024

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

An 85-year-old female underwent convergent procedure via sub-x approach with concomitant left atrial appendage exclusion.Due to moderate bleeding at incision site, resumption of anticoagulant medications post-procedure was held until bleeding stopped.On post-operative day 2, the patient experienced symptoms of slurred speech, which resolved within 24 hours.A ct scan of head showed no damage nor bleeding.The patient was diagnosed with transient ischemic attack (tia).No intervention was performed.The patient recovered as expected and was discharged to home.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 45140 ; 5136448220
• MDR Report Key: 18665220
• MDR Text Key: 334833387
• Report Number: 3011706110-2024-00005
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2024
• 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: PRO250
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Female