MAUDE Adverse Event Report: ATRICURE, INC. CANNULA WITH GUIDE, 30CM

Model Number CSK-6130

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

Patient Problem Cardiac Perforation (2513)

Event Date 04/05/2024

Event Type  Injury  

Event Description

A patient underwent convergent procedure via sub-xiphoid approach.While advancing the cannula, bleeding was observed.Procedural access was converted to median sternotomy and the defect was repaired.There were no reported device malfunctions, and this event was the result of a procedural complication.

Manufacturer Narrative

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.

• Brand Name: CANNULA WITH GUIDE, 30CM
• 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 45040 ; 5136448220
• MDR Report Key: 19206103
• MDR Text Key: 341358927
• Report Number: 3011706110-2024-00032
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P200002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• 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: 04/05/2024
• 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
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 85 KG