MAUDE Adverse Event Report: ATRICURE, INC. SYNERGY¿ ABLATION SYSTEM; SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number OLL2

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2019

Event Type  malfunction  

Event Description

During coronary artery bypass graft procedure, the surgeon was performing the cryomaze and the device was not freezing properly.Device taken off the field and new device (same model) was opened.Case was completed with no harm to the patient.The rep sequestered the device.

• Brand Name: SYNERGY¿ ABLATION SYSTEM
• Type of Device: SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 9933093
• MDR Text Key: 186709673
• Report Number: 9933093
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 97180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25915 DA