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 Component (1104)

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

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not yet been returned to atricure for evaluation.If additional information is received a supplemental report will be submitted.Device has not yet been received.

Event Description

During a stand alone surgical ablation procedure with fusion, the magnet from the device got dislodged falling into patient's chest cavity.The procedure was prolonged for 30 minutes while trying to locate the magnet to be removed.The patient outcome was not affected.

Manufacturer Narrative

(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.Neither the magnet nor the magnet cap were returned with the device.The retriever was returned with the device with a cracked cap.

• 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 ; 5137555320
• MDR Report Key: 5667935
• MDR Text Key: 45574177
• Report Number: 3003502395-2016-00025
• 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,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2018
• Device Model Number: 001-700-001MI
• Device Catalogue Number: 001-700-001MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• 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
• Patient Age: 59 YR
• Patient Weight: 93