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

Model Number COBRA FUSION 150 ABLATION SYSTEM

Device Problem Use of Device Problem (1670)

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

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The cobra fusion 150 was returned for evaluation and visually and functionally tested.The complaint was reported from customer as retriever not functioning or connecting.Fusion 150 device had magnet cap that was broken on two sides and magnet was dislodged.

Event Description

It was reported that on (b)(6) 2020 a patient underwent an off pump surgical ablation procedure to treat afib.The physician was attempting to use the cobra fusion 150 and the magnetic guide but it was not effective as the magnets at the distal end of the introducer and the other end of the retriever did not seem to come together properly.A new guide was retrieved to complete the procedure without any further delays.There was no harm to the patient and they left the or in sinus rhythm.This was a reported device malfunction, no reported adverse event.

• 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
• 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: 11402113
• MDR Text Key: 239575757
• Report Number: 3011706110-2021-00011
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K190151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COBRA FUSION 150 ABLATION SYSTEM
• Device Catalogue Number: 001-700-003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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