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

Model Number 001-700-001S

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104)

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

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon inspection of both devices, the complaint was confirmed.The magnet cap had failed allowing the magnet to be pulled from the distal end of the fusion end effector.

Event Description

During a opcab (off-pump coronary artery bypass) x2 extensive maze ablation left atrial appendage ligation procedure, the magnet in the probe was dislodged from the device and was attached to the introducer.The surgeon used a second fusion device to complete the case.It was later found that the magnet was dislodged from the second device as well.No patient consequence reported.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: ranjana iyer ; 6217 centre park drive; west chester, OH 45069-3886 ; 5137555320
• MDR Report Key: 5595278
• MDR Text Key: 43278283
• Report Number: 3003502395-2016-00019
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 001-700-001S
• Device Catalogue Number: 001-700-001S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• 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): Required Intervention