MAUDE Adverse Event Report: ATRICURE, INC. CANNULA WITH GUIDE

Model Number CSK-6131

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

Patient Problem Cardiac Perforation (2513)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation and a device history record 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 (b)(6) 2023, a male patient underwent a hybrid convergent procedure.After making a sub-xiphoid incision on and creating a pericardial window, the epi-sense st cannula was inserted into the pericardiotomy.Upon inserting the cannula, blood was visualized, and the cannula was withdrawn.Procedure was converted to a median sternotomy and the injury was repaired with a suture.Procedure was completed and patient was in normal sinus rhythm post-operatively.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: CANNULA WITH GUIDE
• Type of Device: CANNULA WITH GUIDE
• 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 ; 5136448220
• MDR Report Key: 17875900
• MDR Text Key: 324976757
• Report Number: 3011706110-2023-00034
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSK-6131
• Device Catalogue Number: CSK-6131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• 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
• Treatment: SUCTION, OLH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male