MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION50 ABLATION SYSTEM; COBRA FUSION 50 SURGICAL SYSTEM

Model Number 700-002

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 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon inspection the magnet had pulled from the distal assembly, complaint was confirmed.Corrective action initiated, the magnet cap design has been changed from a bonded joint to a cap with a lip which houses the magnet.

Event Description

It was reported during a fusion convergent procedure, the magnet on the guiding catheter for the fusion magnetic system became dislodged from the device.Fortunately, because of the " magnetic" component, it stuck to the counterpart side of the device, and remained on the device.They removed it from the sterile field, and opened a separate device.The patient was off pump and heparinized, but it is unknown how much.The case was delayed for the time it took to get another device and open in the sterile field.The patient outcome was not affected.

• Brand Name: COBRA FUSION50 ABLATION SYSTEM
• Type of Device: COBRA FUSION 50 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 6217 centre park dr.; west chester OH 45069 3886
• Manufacturer Contact: ranjana iyer ; 6217 centre park dr.; west chester, OH 45069-3886 ; 5137555328
• MDR Report Key: 5798817
• MDR Text Key: 49744670
• Report Number: 3003502395-2016-00042
• 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: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 700-002
• Device Catalogue Number: 700-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• 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: 60 YR