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

Model Number COBRA FUSION 150 ABLATION MININALLY INVASIVE SYSTEM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the device was returned and functionally and visually evaluated.The complaint was confirmed upon receipt of the product.The magnet had dislodged from the fusion 150 distal magnet cap.The magnet was returned with the product.The swivel positioner was visually inspected and passed.

Event Description

A (b)(6) male had a mi surgical ablation procedure with cobra fusion 150 where the magnet became dislodged from the fusion 150 and had stuck to the magnetic handle.The sequence of this taking place was at the moment of retrieval of the fusion 150 out of the patient.The patient was off pump and heparinized with an unknown amount.The patient care and case outcome were 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.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: anupam bedi
• MDR Report Key: 6764882
• MDR Text Key: 81851861
• Report Number: 3011706110-2017-00067
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2017

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: Other Health Care Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: COBRA FUSION 150 ABLATION MININALLY INVASIVE SYSTEM
• Device Catalogue Number: 001-700-001MI
• Device Lot Number: RW8029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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: 74
• Patient Weight: 77