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

Model Number 001-700-001MI

Device Problem Detachment Of Device Component (1104)

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

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

Complaint number: (b)(4).The device was received and sent to atricure engineering for analysis.The complaint was confirmed, the magnet cap had failed allowing the magnet to be pulled from the distal end of the fusion end effector.Magnet was returned stuck to the swivel positioner.

Event Description

It was reported during a procedure the magnetic tip came outside of its normal location.The doctor was using the dedicated instrument to move the fusion.The magnetic tip on the top of the fusion had remained attached to the magnetic stylet coming out from the device and did not fall into the patient.The patient was off pump and their outcome was not affected.

• Brand Name: COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION MINIMALLY 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 ; 5137555320
• MDR Report Key: 5798996
• MDR Text Key: 49758112
• Report Number: 3003502395-2016-00045
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/20/2016

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: Health Professional
• Device Model Number: 001-700-001MI
• Device Catalogue Number: 001-700-001MI
• Device Lot Number: 59063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2016
• Initial Date FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 76 YR