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

Model Number 001-700-001S

Device Problems Loss of or Failure to Bond (1068); Material Separation (1562); Material Integrity Problem (2978)

Patient Problems Stroke/CVA (1770); Thrombus (2101)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was returned to atricure for evaluation.During examination, the magnet cap was found to contain cracks which lead to the reported magnet dislodgement.Therefore, this portion of the complaint was confirmed.However, there was nothing found that is believed to have contributed to the patient's adverse event.

Event Description

It was reported by the sales rep.That during a tt maze procedure, using the atricure fusion 150 device, the magnet at the distal end of the device, dislodged.The facility reattached the magnet with dermabond, and proceed with the surgery.Post-operatively, it was reported (b)(6) 2015, the patient was in sinus rhythm but woke up sleepy and confused.A mri indicated that the patient had multiple significant embolic strokes on the left and right side.The patient was off by-pass pump and heparinized with 5000 units used during right side ablations, and none on the left side.The patient was released to rehab friday, (b)(6) 2015.He is conversing and may be blind in one eye.The neurologist is optimistic of his recovery.Although there was a report of a dislodged magnet, the magnet is not believed to be the cause or associated with the adverse event.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 6217 centre park dr.; west chester OH 45069 3886
• Manufacturer Contact: john huff ; 6217 centre park dr.; west chester, OH 45069-3886 ; 5136444125
• MDR Report Key: 5252004
• MDR Text Key: 32197280
• Report Number: 3003502395-2015-00043
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/04/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: 001-700-001S
• Device Catalogue Number: 001-700-001S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 82