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

Model Number 001-700-001S

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

Patient Problems Stroke/CVA (1770); Tissue Damage (2104); Blood Loss (2597)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned to atricure for evaluation, device was disposed off by the hospital.The lot number of the device was unable to be ascertained.Device was discarded by facility.

Event Description

It was reported by the sales rep that the surgeon performed a right thoracotomy stand alone ablation procedure, which went smoothly with no equipment or device issues.After ablating, there was a small bleed on the dome of the atrium that was difficult to manage.After trying unsuccessfully to control the bleeding using surgicell, the surgeon eventually gave the patient protamine, and the bleeding stopped.During the procedure, the patient was not on a by-pass pump, and was anticoagulated with 10k heparin.Since the patient had a bmi of 55, the patient may not have been fully anticoagulated.Three days post -op, the rep.Was notified that the patient had a small cva.The cva caused speech issues, although they are getting better and the patient is expected to make a full recovery.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer (Section G): ATRICURE, INC; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: john huff ; 6217 centre park drive; west chester, OH 45069-3886 ; 5136444725
• MDR Report Key: 5223448
• MDR Text Key: 31179620
• Report Number: 3003502395-2015-00042
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 001-700-001S
• Device Catalogue Number: 001-700-001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• 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): Hospitalization; Life Threatening; Required Intervention