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

Model Number COBRA FUSION 150 ABLATION MININALLY INVASIVE SYSTEM

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned and visual and functional evaluated.The complaint was confirmed.The swivel positioner magnet cap face had become dislodged from the swivel base/ magnet holder, allowing the magnet to become dislodged.

Event Description

During a surgical ablation with the cobra fusion where the patient was off pump and heparinized, the magnet from the fusion 150 came out from its place, remaining connected to the tip of the fusion 150.Patient care and outcome were not affected as the procedure was able to be completed with this device.

• Brand Name: COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION MINIMALLY INVASIVE 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: 6766685
• MDR Text Key: 81851977
• Report Number: 3011706110-2017-00068
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: COBRA FUSION 150 ABLATION MININALLY INVASIVE SYSTEM
• Device Catalogue Number: 001-700-001MI-EU
• Device Lot Number: 66130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1