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  

Event Description

"during a literature search, atricure determined a patient experienced an adverse event prior to 2022 which may have been caused or contributed to by the csk-6130 cannula.At the nashville chest cardiothoracic surgery meeting on (b)(6) 2022 it was reported that a patient underwent the convergent procedure via transdiaphragmatic approach for treatment of long-standing persistent atrial fibrillation.There were no perioperative complications noted.Two years after undergoing the procedure, the patient received ct angiogram for another condition, which incidentally revealed a loop of transverse colon herniated through the diaphragmatic incision site, and incarcerated within the pericardial sac.The patient was asymptomatic and physical exam was unremarkable.Surgical correction of the hernia was recommended, but the patient elected for close monitoring and reconsideration of surgical repair at a later date.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: chohan a.Crawford a.Pericardial hernia following convergent hybrid ablation for atrial fibrillation.Nashville chest 2022.Cardiothoracic interventions 1; rapid fire case reports.10/18/2022.Doi: https://doi.Org/10.1016/j.Chest.2022.08.050.".

• 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 45040 ; 5136448220
• MDR Report Key: 18720608
• MDR Text Key: 335705143
• Report Number: 3011706110-2024-00015
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• 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

• 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
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• 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: 71 YR
• Patient Sex: Male