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

Model Number OLL2

Device Problems Display or Visual Feedback Problem (1184); Protective Measures Problem (3015)

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

Event Date 09/14/2018

Event Type  malfunction  

Event Description

The radiofrequency (rf) atricure probe was having issues.Unable to complete the ablation with this probe, and rf machine was showing abnormal waveforms.The unit displayed an error code, and a picture of this was sent to the rep.The patient was on the pump, and heparinized.There was a surgical delay of 5 to 10 minutes.The maze procedure was then able to be completed after opening another oll2 atricure and pulled another rf machine.The asu (ablation sensing unit) had been used once prior to this problem.Manufacturer response for surgical cardiac ablation device, for treatment of atrial fibrillation, synergy ablation system (per site reporter).They requested information regarding the case and have provided a shipper kit to return the device to them.

• Brand Name: SYNERGY ABLATION SYSTEM
• Type of Device: SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ATRICURE, INC.; 6217 centre park drive; west chester OH 45069
• MDR Report Key: 7968645
• MDR Text Key: 123818530
• Report Number: 7968645
• Device Sequence Number: 1
• Product Code: OCM
• UDI-Device Identifier: 00818354010503
• UDI-Public: (01)00818354010503(17)210501(10)83943
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• 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: 83943
• 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: 10/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33215 DA
• Patient Weight: 78