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

Model Number CRYOS-L

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

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Case (b)(4) the device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the cryos-l device was not reported or able to be subsequently ascertained.The complaint could not be confirmed.

Event Description

It was reported on 8 oct 2019, that (procedure date is unknown) a patient underwent a successful robotic video-assisted thoracoscopic surgery.Post-procedure, the patient experienced severe neuralgia, had to be re-hospitalized for irretraceable pain and treated with steroids and epidural.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: CRYOICE CRYOSPHERE PROBE
• Type of Device: CRYOICE CRYOSPHERE 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 ; 5137554563
• MDR Report Key: 9283886
• MDR Text Key: 166303728
• Report Number: 3011706110-2019-00052
• Device Sequence Number: 1
• Product Code: GXH
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CRYOS-L
• Device Catalogue Number: A001012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: No
• 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