MAUDE Adverse Event Report: ATRICURE, INC. CRYOICE CRYOSPHERE CRYO-ABLATION PROBE

Model Number CRYOS

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

Patient Problem Cryogenic Burn (4539)

Event Date 12/13/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient underwent a pectus repair with cryo nerve block.Tissue near the incision site came in contact with the cryos probe and discolored.Surgeon elected to excise this tissue.The procedure was completed, and there were no additional reported complications with the patient.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Manufacturer Narrative

(b)(4).The cryos device was returned for evaluation and investigation confirmed that the external probe surface was at or below 0 celsius, which could have resulted in the reported skin freeze.

• Brand Name: CRYOICE CRYOSPHERE CRYO-ABLATION PROBE
• Type of Device: CRYOICE CRYOSPHERE CRYO-ABLATION 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: 16147070
• MDR Text Key: 307181835
• Report Number: 3011706110-2023-00002
• Device Sequence Number: 1
• Product Code: GXH
• UDI-Device Identifier: 10840143902543
• UDI-Public: (01)10840143902543(17)250901(10)123352
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182565
• 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
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CRYOS
• Device Catalogue Number: A001009
• Device Lot Number: 123352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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): Required Intervention