MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION 150 SURGICAL SYSTEM

Model Number 700-001S

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Device Handling Problem (3265)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 03/03/2015

Event Type  Injury  

Event Description

It was reported during a surgical procedure the surgeon could not successfully find a correct position for the fusion 150 device on the patient's atrium.He finally decided to stop the procedure.A few moments later, he noticed bleeding coming from circumflex artery.The surgeon noticed several dislodged electrodes protruding from the device's probe.The surgeon used sutures to repair the circumflex artery, causing the patient to remain on pump bypass an additional hour.

Manufacturer Narrative

(b)(4).Upon receipt, the device was evaluated and was confirmed to have several dislodged electrodes.Electrode dislodgement is believed to be caused by using forceps or metal graspers, in the electrode area instead of the areas indicated, to reposition the device.Device met all electrical specifications.

• Brand Name: COBRA FUSION 150 SURGICAL SYSTEM
• Type of Device: COBRA FUSION 150 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; west chester OH
• Manufacturer Contact: john huff ; 6217 centre park dr; west chester, OH 45069
• MDR Report Key: 4755817
• MDR Text Key: 5771431
• Report Number: 3003502395-2015-00015
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 700-001S
• Device Lot Number: 13672-100714
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 05/05/2015
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 47 YR