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 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 2016 which may have been caused or contributed to by the csk-6130 cannula.In a 2017 published case study within "oxford medical case reports" a 59-year-old female patient with highly symptomatic recurrent paroxysmal atrial fibrillation.The patient underwent the convergent atrial fibrillation ablation procedure via transdiaphragmatic approach.Four months after the procedure, she complained of constant bloating.Chest ct confirmed a diaphragmatic hernia, with portions of greater omentum and transverse colon extending into the pericardial space.Laparoscopic hernia repair was performed.The patient recovered without additional complications.There was no reported device malfunction and the reported adverse event is a result of procedural complication.Sub-xiphoid access is the preferred approach for the convergent procedure.Source: shrestha s, john j, jacobowitz i, greenberg y, yang f.Pericardial hernia: an unusual complication of convergent atrial fibrillation ablation.Oxf med case reports.2016;5:107¿ 108.

• 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: 18717693
• MDR Text Key: 335526779
• Report Number: 3011706110-2024-00012
• 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): Required Intervention; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female