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

Model Number OLL2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

Event Type  malfunction  

Event Description

During ablation, the atricure was placed over the tissue during attempted ablation.The ablation line (burn) on the monitor never dropped below baseline indicating the burn was never completed.Another device was utilized without issue.This patient was not negatively impacted.

• 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: 8304257
• MDR Text Key: 134996089
• Report Number: 8304257
• Device Sequence Number: 1
• Product Code: OCM
• UDI-Device Identifier: 00818354010503
• UDI-Public: (01)00818354010503(17)211101(10)88837
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 88837
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA