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 Perforation (2001)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

Case-(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 csk-6130 device was not reported or able to be subsequently ascertained.

Event Description

It was reported that on (b)(6) 2021 a (b)(6)-year-old male patient underwent a convergent procedure with left atrial appendage management.As the surgeon crossed over the inferior vena cava (ivc) with the csk-6130 the ivc tore.The procedure was converted to a sternotomy and the tear was fixed.The procedure was completed and as of 2 days post-op, the patient was awake and in normal sinus rhythm.This was a procedural complication and there was no reported device malfunction.

• 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: 11862374
• MDR Text Key: 251925864
• Report Number: 3011706110-2021-00021
• 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: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2021
• 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): Required Intervention
• Patient Age: 45 YR