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

Model Number 001-700-001MI

Device Problems Failure To Adhere Or Bond (1031); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 concomitant cabag procedure, the magnet located in the introducer system became detached and fell into the thoracic cavity.The magnet was located and removed with delay in procedure for five minutes.Another fusion device was used to complete the case.The patient outcome was not affected.

• Brand Name: COBRA FUSION 150 ABLATION MININALLY INVASIVE SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION MININALLY INVASIVE 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 ; 5137555328
• MDR Report Key: 5549388
• MDR Text Key: 41938651
• Report Number: 3003502395-2016-00014
• 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: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 001-700-001MI
• Device Catalogue Number: 001-700-001MI
• Device Lot Number: 59062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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