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 was not reported or able to be subsequently ascertained.

Event Description

It was reported on (b)(6) 2019 that a patient underwent a successful robotic video-assisted thoracoscopic surgery (procedure date unknown).Post-procedure the patient experienced severe neuralgia and bulging of the rectus muscles.Patient had to be re-hospitalized for irretraceable pain and treated with steroids and epidural.There was no 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 ; 5136448220
• MDR Report Key: 9286044
• MDR Text Key: 165573899
• Report Number: 3011706110-2019-00054
• 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: A001009
• 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): Hospitalization; Required Intervention