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

Model Number ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, LONG JAW, LE

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/09/2022

Event Type  Death  

Manufacturer Narrative

Case (b)(4).The oll2 device was not returned for evaluation; however, the device history record was reviewed for oll2 - lot number 111585 and there is nothing in the product history record that would indicate that the devices were released with any non-conformances that would contribute to the subject complaint.

Event Description

On (b)(6) 2022 a patient with a history of rheumatic disease, fragile cardiac tissue and a thin cardiac wall underwent an on-pump mv-replacement, maze procedure, and left atrial appendage exclusion.The procedure was uneventful but during decannulation multiple bleeds were detected.The patient went back on bypass to fix the bleeds, and more bleeding occurred during manipulation on the heart.After extensive repair, the patient was moved to icu but drainage showed a significant amount of blood.Patient went back to the or for re-exploration, where they detected bleeding from the left superior pulmonary vein (lspv) at the ablation line.The bleeding was repaired, but during recovery the patient expired.This is a procedural event and there was no reported device malfunction.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ATRICURE 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: 13692925
• MDR Text Key: 286837633
• Report Number: 3011706110-2022-00006
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, LONG JAW, LE
• Device Catalogue Number: A000362
• Device Lot Number: 111585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/10/2022
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2021
• 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): Death
• Patient Sex: Female