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

Model Number 001-700-001S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 11/09/2015

Event Type  Injury  

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 was discarded by customer.

Event Description

On (b)(6) 2015, the surgeon performed an urgent cabg x 5 procedure, with left atrial ablation box lesions and laa occlusion on a (b)(6) male patient.The ablations were performed using the atricure fusion 150 device.The ablations were performed after bypass was initiated, but before cross-clamping.The patient was on by-pass pump and heparinized to an act>440.During the procedure, the fusion 150 device functioned as intended and no malfunctions or defects were reported.There were no delays in the surgical procedure, and no back-up method was required.On (b)(6) 2015, the atricure rep.Was notified the patient experienced a stroke during the procedure.The patient was discharged to rehab on pod 6 with minimal neurological deficit.Patient is on coumadin.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: john huff ; 6217 centre park drive; west chester, OH 45069-3886 ; 5136444725
• MDR Report Key: 5308180
• MDR Text Key: 33824766
• Report Number: 3003502395-2015-00049
• 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: 11/20/2015

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: Physician
• Device Expiration Date: 07/01/2018
• Device Model Number: 001-700-001S
• Device Catalogue Number: 001-700-001S
• Device Lot Number: 59058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2015
• 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: 64 YR