MAUDE Adverse Event Report: ATRICURE, INC. CANNULA ACCESSORIES

Model Number CSK-6130

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

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Hernia (2240)

Event Type  Injury  

Event Description

During a literature search, atricure determined a patient experienced an adverse event on a date prior to 2020 which may have been caused or contributed to by the csk-6130 cannula.Recorded at the 2020 sages virtual meeting, the video reports a patient experienced acute onset dysphagia and po intolerance.The patient had undergone transdiaphragmatic approach convergent procedure for treatment of afib 3 years prior.A ct scan showed a diaphragmatic hernia through the central tendon incision.The patient was taken to or for mobilization and reduction of stomach and lower esophagus from within chest.A 4x10cm diaphragmatic defect was closed with suture.The patient recovered without further reported complication.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: dyke c, ritter em.Laparoscopic central diaphragmatic incisional hernia repair after convergent maze procedure.Foregut abstracts session.2020 sages virtual meeting.Sages minimally invasive surgery videos 20-jul-2023.

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 was not reported.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: 18720566
• MDR Text Key: 335575679
• Report Number: 3011706110-2024-00014
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/16/2024
• 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; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male