MAUDE Adverse Event Report: ATRICURE, INC. CANNULA ACCESSORIES

Model Number CSK-6130

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

Patient Problem Cardiac Perforation (2513)

Event Date 03/24/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient underwent a convergent with left atrial appendage management (laam) procedure.During the convergent portion of the procedure, the sub-xiphoid incision was made and the pericardium was opened.During positioning of the cannula, the physician observed bleeding.The patient was put onto bypass and a sternotomy was performed.The physician stated the patient had adhesions the prevented the normal movement of the heart during positioning.A lesion on the right ventricle was repaired and the procedure was completed.Post-op day-7, patient was doing well and in normal sinus rhythm.This was a procedural complication and there was no reported device malfunction.

Manufacturer Narrative

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

• Brand Name: CANNULA ACCESSORIES
• Type of Device: CANNULA ACCESSORIES
• 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: 14167941
• MDR Text Key: 289758754
• Report Number: 3011706110-2022-00009
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSK-6130
• Device Catalogue Number: CSK-6130
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/21/2022
• 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: CRYO PROBE, ATRICLIP, EPISENSE
• Patient Outcome(s): Required Intervention; Life Threatening