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 08/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4) the cryos device was returned for evaluation and visually and functionally tested.The complaint could not be confirmed as cryos device met operating specifications.

Event Description

On (b)(6) 2022 that a male patient underwent an off-pump, nuss / cryo-nerve block (cnb) procedure.During the cnb, the physician noticed an area of frostbite on the patient's skin.The impacted skin was excised.Post procedure, patient was doing well.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• 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: 15331399
• MDR Text Key: 299038595
• Report Number: 3011706110-2022-00030
• Device Sequence Number: 1
• Product Code: GXH
• UDI-Device Identifier: 30840143902912
• UDI-Public: (01)30840143902912(17)250101(10)116705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180138
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• 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: 116705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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
• Patient Sex: Male