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

Model Number	CRYOS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Cryogenic Burn (4539)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Case-(b)(4) - device has not been returned for investigation.The device will be investigated upon return.If investigation results indicate there was a product malfunction that caused the reported event a supplemental report will be filed.
Event or Problem Description
On (b)(6) 2023 a male patient underwent a video-assisted thoracoscopic nuss procedure with concomitant cryo nerve block using a cryos probe.During procedure, surgeon released the lung following a freeze application.The cryos probe adhered to lung tissue during removal.As a precaution, the surgeon did wedge resection of the portion of lung tissue that adhered to the probe, in order to prevent a possible delayed pneumothorax.There was no confirmed device malfunction, and this event was the result of a procedural complication.

• Brand Name: CRYOICE CRYOSPHERE CRYOABLATION PROBE
• Common Device Name: CRYOICE CRYOSPHERE 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 45040 ; 5136448220
• MDR Report Key: 18443015
• Report Number: 3011706110-2024-00001
• Device Sequence Number: 20520961
• Product Code: GXH
• UDI-Device Identifier: 10840143902543
• UDI-Public: (01)10840143902543(17)260901(10)133543
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K200697
• 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): 01/04/2024

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 Expiration Date: 09/01/2026
• Device Model Number: CRYOS
• Device Catalogue Number: A001009
• Device Lot Number: 133543
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• 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
• Patient Sex: Male