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

Model Number COBRA FUSION 150 ABLATION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4).The device was not returned to atricure for evaluation and a device history review was unable to be completed as the relevant device lot number was not reported.The device was discarded by the facility as there was no report of any malfunctions.

Event Description

During a discussion with a surgeon, there was a recent case of a mvr and maze procedure via sternotomy were the patient was on bypass and fully heparinized and the fusion 150 was used for the ablation.After the ablation was complete, the surgeon opened the left atrium and observed a pea sized clot on the burn line of where the fusion was used.The surgeon was unsure of the exact position within the left atrium where the clot was observed but was somewhere along the burn line.The sales representative has a discussion with the surgeon to reemphasize the importance of using fusion within the recommendations of the ifu.

Manufacturer Narrative

(b)(4).This adverse event is reported for a female patient, (b)(6).The patient age at the time of the incident was (b)(6) years.Additionally, the surgeon was able to evacuate the clot during the procedure.No device evaluation was performed.No further update available.

• 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: anupam bedi
• MDR Report Key: 6675308
• MDR Text Key: 78653625
• Report Number: 3011706110-2017-00058
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: COBRA FUSION 150 ABLATION SYSTEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/01/2017
• Date Manufacturer Received: 06/01/2017
• 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): Life Threatening
• Patient Age: 57 YR
• Patient Weight: 171