MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION 150 ABLATION SYSTEM

Model Number 001-700-001S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the cobra fusion 150 device was not returned for evaluation, but a device history review was obtained for lot number 89997.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

It was reported that on (b)(6) 2020 a male patient underwent an off pump heparinized total thoracoscopic maze surgical procedure with the fusion device.Patient was heparinized for the procedure.The surgeon completed the cardiac ablation procedure, at the completion of procedure the surgeon noted that the magnetic retriever got disconnected from the tip of the fusion catheter.The magnet was left were it was, on the tip of the catheter, and the surgeon carefully took out the fusion catheter without losing the magnet.There was no impact to the patient care or procedure outcome.

Manufacturer Narrative

(b)(4) the cobra fusion 150 device lot number 89997 was returned for evaluation and visually and functionally tested.The complaint was confirmed.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 10441640
• MDR Text Key: 204048065
• Report Number: 3011706110-2020-00025
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 001-700-001S
• Device Catalogue Number: 001-700-001S
• Device Lot Number: 89997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1