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

Model Number 001-700-001MI

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 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device history review was completed and an additional visual inspection was conducted on the magnet cap for this particular lot.This lot is part of the advisory notice.No device returned.

Event Description

During manipulation of the cobra fusion catheter around the pulmonary vein, the magnet from the tip of the catheter was dislodged.This resulted in a 10 minute delay.The case was completed and the patient 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.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; atricure, inc.; 7555 innovation way; mason, OH 45040 ; 5137555320
• MDR Report Key: 6065049
• MDR Text Key: 58746626
• Report Number: 3003502395-2016-00145
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: 001-700-001MI
• Device Catalogue Number: 001-700-001MI
• Device Lot Number: 59063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3011706110-09/22/2016-C
• Patient Sequence Number: 1