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

Model Number COBRA FUSION 150

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for evaluation and visually and functionally tested pursuant to (b)(4).Upon inspection it was found that the electrodes on the active and inactive side were pulled from the device.This particular lot was identified as one that was built in the time frame in which rev 05 electrodes were being used in production.Electrode dislodgement has been investigated per (b)(4) and concluded that all electrode dislodgement complaints have been from devices built with rev 05 electrodes.Per (b)(4), the electrodes were updated, implemented into production, and as a result, since this complaint, the electrode dislodgement issue has since been mitigated.

Event Description

During a mv repair, cabg, and pv isolation procedure, sections 1 and 2 on the probe were faulty.All other sections functioned well and as expected.The patient was off pump and outcome was not affected.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555328
• MDR Report Key: 6307513
• MDR Text Key: 66780577
• Report Number: 3003502395-2017-00022
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/29/2017
• Device Model Number: COBRA FUSION 150
• Device Catalogue Number: 001-700-001S
• Device Lot Number: 13433-060214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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 Age: 55 YR