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 Cardiac Arrest (1762); Ventricular Fibrillation (2130); Obstruction/Occlusion (2422)

Event Date 05/20/2021

Event Type  Death  

Manufacturer Narrative

Case-(b)(4) the epi-sense device was not returned for evaluation, but a device history review was obtained for lot number 105998.There is nothing in the device history record that would indicate that the devices were released with any non-conformance that would contribute to the complaint.

Event Description

It was reported on (b)(6) 2021 a (b)(6) year-old male patient underwent a convergent procedure.The surgeon successfully ablated the posterior wall of the left atrium.After the ablation procedure, the patient went into ventricular fibrillation.External means of converting the patients rhythm failed, and the procedure was converted to a sternotomy to internally manipulate the heart back into sinus rhythm.There were no signs of damage to the heart anatomy from the convergent procedure, and assessment determined there was significant blockage of the left anterior descending artery (lad), despite a previous stent.Two additional stents were placed.Following the surgical intervention, patient condition deteriorated and the patient ultimately passed away.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Manufacturer Narrative

(b)(4).The cannula device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the cannula device was not reported or able to be subsequently ascertained.Corrected device information submitted.

• Brand Name: CANNULA ACCESSORIES
• Type of Device: CANNULA ACCESSORIES
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 12025321
• MDR Text Key: 257115040
• Report Number: 3011706110-2021-00031
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K193162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

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 Expiration Date: 10/01/2023
• Device Model Number: CSK-6130
• Device Catalogue Number: CSK-6130
• Device Lot Number: 105998
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/18/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CSK-6130
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 132