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 Consequences Or Impact To Patient (2199)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation, however, the device history record was reviewed and no non-conformance or reworks were noted during the manufacturing process that relate to the reported issue.Device not received yet.

Event Description

It was reported during unilateral thoracoscopic maze case, after the ablation was completed, the magnet was found at the swiveled handle.The procedure was prolonged five minutes and was completed using the same device.The patients outcome was not affected.The magnet did not fall into the patient.

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.The magnet was returned attached to the positioner.

• 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: 5717075
• MDR Text Key: 47216232
• Report Number: 3003502395-2016-00046
• 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: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• 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: 59278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• 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