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 Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(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 device was not reported or able to be subsequently ascertained.

Event Description

"during a literature search, atricure determined a patient experienced an adverse event prior to 2013 which may have been caused or contributed to by the csk-6130 cannula.An abstract from the 2013 sages meeting reported a patient presented to etc with acute onset epigastric abdominal pain with nausea.Convergent procedure via transdiaphragmatic access was performed at a different facility five months prior to presentation.Ct demonstrated a diaphragmatic hernia containing transverse colon.Patient was taken to or for laparoscopic reduction of hernia with repair using two hernia patches.The patient was discharged and was free of symptoms on surgical follow-up.There was no reported device malfunction, and the adverse event was the result of a procedural complication.Sub-xiphoid access is the preferred approach for the convergent procedure.Source: datta ts, breard jp, guirkin t.Incarcerated diaphragmatic hernia after convergent maze procedure.Sages abstract archives.10/22.Session: video channel day 1.Program number: v037.".

• Brand Name: CANNULA ACCESSORIES
• Type of Device: CANNULA
• 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 45140 ; 5136448220
• MDR Report Key: 18717443
• MDR Text Key: 335522927
• Report Number: 3011706110-2024-00007
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 01/19/2024
• 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): Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: Black Or African American