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 Vomiting (2144); Hernia (2240); Discomfort (2330)

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 was not reported.There was no reported device malfunction.

Event Description

During a literature search, atricure determined a patient experienced an adverse event prior to 2019 which may have been caused or contributed to by the csk-6130 cannula.Literature reported a patient with persistent atrial fibrillation, severe tricuspid regurgitation and pulmonary hypertension underwent a convergent procedure via transdiaphragmatic access.Two and a half years later, the patient presented with acute onset of severe epigastric pain and associated nausea and vomiting.Ct angiogram of the chest revealed small bowel herniation with ventricular compression.A laparotomy was performed to reduce the herniated small bowel through the diaphragmatic defect.Additionally, the falciform ligament was secured with sutures.The patient recovered and was discharged to home on pod6.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: bloom j, etolis g, fitton t.Cardiac tamponade due to a strangulated visceral pericardial hernia after convergent procedure.Ctsnet.Https://www.Ctsnet.Org.9-oct-2019.".

• 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: 18720771
• MDR Text Key: 335578531
• Report Number: 3011706110-2024-00016
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male