MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR® SYNERGY SURGICAL ABLATION SYSTEM; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING

Model Number	EMR2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Pneumonia (2011)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent ablation procedure for inappropriate sinus tachycardia (ist) as part of ide # (b)(4).The patient was heparinized during the procedure, which was successfully completed, after which the patient was discharged to home.The patient had medical history of prior venous thromboembolism and type ii diabetes mellitus.On pod 6, the patient presented to the ed with right-sided chest pain and dyspnea, and was diagnosed with pneumonia for which antibiotics were prescribed.On pod 12, the patient presented to the ed with chest pain and shortness of breath.A ct-angiogram confirmed pulmonary emboli within bilateral lower lobar pulmonary arteries.The patient was medically managed with heparin drip, then transitioned to eliquis.Both the adverse events of pneumonia and pulmonary embolism were assessed by clinical trial investigator with "unknown" relatedness to index procedure, and not related to atricure investigational device.While it is not possible to identify cause or contribution of the emr2 device, this event is being reported per part 803.There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Additional Manufacturer Narrative
The device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number was not reported.There was no reported device malfunction.

• Brand Name: ISOLATOR® SYNERGY SURGICAL ABLATION SYSTEM
• Common Device Name: SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
• 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: 19397192
• Report Number: 3011706110-2024-00039
• Device Sequence Number: 15190015
• Product Code: OCL
• UDI-Device Identifier: 00818354010756
• UDI-Public: 00818354010756
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K221358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EMR2
• Device Catalogue Number: A000452
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMR2, ASU3, ASB3
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 36 YR
• Patient Sex: Male