MAUDE Adverse Event Report: ATRICURE, INC. CRYOFORM CRYOICE CRYOABLATION PROBE

Model Number	CRYOF+
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a mitral valve repair/replacement with concomitant maze.Procedure was completed successfully, and the patient was taken off bypass.Upon closing the patient chest, blood was noticed in the drain tubes.The patient's pressure dropped, and a sternotomy was performed.The patient was placed back on bypass and an injury was located between the base of the left atrial appendage and the left pulmonary veins.The injury was repaired.Patient recovery was optimal, and patient was discharged home.There was no reported device malfunction, and the event was the result of a procedural complication.
Additional Manufacturer Narrative
(b)(4).The device was not returned for investigation and no device malfunction was alleged.There is nothing in the device history record that would indicate the devices were released with any non-conformances that would contribute to the subject complaint.

• Brand Name: CRYOFORM CRYOICE CRYOABLATION PROBE
• Common Device Name: CRYOFORM CRYOICE CRYOABLATION PROBE
• 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 ; 5136448220
• MDR Report Key: 16704261
• Report Number: 3011706110-2023-00016
• Device Sequence Number: 12166572
• Product Code: GEH
• UDI-Device Identifier: 10840143902505
• UDI-Public: (01)10840143902505(17)250501(10)120189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2023

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 Expiration Date: 05/01/2025
• Device Model Number: CRYOF+
• Device Catalogue Number: A000957-6
• Device Lot Number: 120189
• 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: 03/08/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown