MAUDE Adverse Event Report: ATRICURE, INC. SYNERGY¿ ABLATION SYSTEM

Model Number OLL2

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

Patient Problem Cardiac Perforation (2513)

Event Date 09/17/2021

Event Type  Death  

Manufacturer Narrative

Case- (b)(4) the oll2 device was not returned for evaluation, but a device history review was obtained for lot number 111400.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

It was reported that on (b)(6) 2021, an (b)(6)-year-old male patient underwent an on-pump, heparinized intra-aortic balloon pump insertion, mammary take down, triple coronary artery bypass graft, bi-atrial maze, a left atrial appendage ligation, and aortic valve replacement.Upon completion of these procedures while coming off cardiopulmonary bypass, bleeding was noted.The patient was placed back on cardiopulmonary bypass, and the heart was re-arrested to repair the left atrial roof line.Patient was stable post-procedure.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Manufacturer Narrative

Case-(b)(4) updated fields b2 and h1 as it was later learned that the patient expired.There is no cause of death and no autopsy results.

• Brand Name: SYNERGY¿ ABLATION SYSTEM
• Type of Device: SYNERGY¿ ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 12605208
• MDR Text Key: 280945219
• Report Number: 3011706110-2021-00043
• Device Sequence Number: 1
• Product Code: OCM
• UDI-Device Identifier: 00818354010503
• UDI-Public: 00818354010503
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 111400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CRYO2, PROV50, ASU/ASB.
• Patient Outcome(s): Life Threatening; Required Intervention; Death
• Patient Age: 83 YR
• Patient Sex: Male