MAUDE Adverse Event Report: ATRICURE, INC. CANNULA ACCESSORIES

Model Number CSK-6130

Device Problem Use of Device Problem (1670)

Patient Problem Perforation of Vessels (2135)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4) the csk-6130 device was not returned for evaluation and a device history review was unable to be completed as the lot number for the device was not reported or able to be ascertained.

Event Description

On (b)(6) 2022, a patient underwent a convergent procedure with left atrial appendage exclusion.The surgeon struggled creating the pericardial window and placed the cannula but was unable to identify landmarks due to adhesions near the apex of the heart.While searching for landmarks, the inferior vena cava was torn.The physician converted the procedure to an open sternotomy and repaired the injury with sutures.Patient was stable post-procedure.This was a procedural complication.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: 14487866
• MDR Text Key: 292497573
• Report Number: 3011706110-2022-00019
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• 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
• Date Manufacturer Received: 04/27/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention