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

Model Number CRYO2

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

Patient Problems Pneumothorax (2012); Injury (2348)

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 was not reported.There was no reported device malfunction.

Event Description

On (b)(6) 2018 it was reported that a review of 29 - nuss procedures completed by 6 different surgeons was done.The review of cases by the practice showed that of the 29 cases done within the last 6 months, 6 patients had confirmed pneumothorax and one of those 6 patients sustained a lung injury that extended the hospital stay by 2 days.Further information was that all patients fully recovered.

• Brand Name: CRYOICE CRYO-ABLATION PROBE
• Type of Device: CRYOICE 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: scott ehlert ; 7555 innovation way; mason, OH 45040
• MDR Report Key: 7698269
• MDR Text Key: 114319638
• Report Number: 3011706110-2018-00189
• Device Sequence Number: 1
• Product Code: GXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142203
• 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: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CRYO2
• Device Catalogue Number: A000683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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