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

Model Number ATRICURE CRYO PEN (UNKNOWN)

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

(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 cryo device was not reported or able to be subsequently ascertained.

Event Description

Surgeon reported that he was having an issue with a patient he used cryo device in (b)(6) 2018, for a surgical procedure for broken ribs where he had to plate the ribs back together.The surgeon resected the bottom lip of the rib, exposed the neurovascular bundle and froze levels 7-10 nerve externally, at least 6cm away from the transverse process laterally under each rib for pain management.Two months post-procedure patient has a bulge posterolateral, lower flank, consistent with lower thoracoabdominal wall denervation.Patient is undergoing physiotherapy.This event is a procedure related complication.Atricure does not recommend ablation below the 9th intercostal space per cryoanalgesia procedural guide (b)(4).There was no reported device malfunction.

• 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: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5137554563
• MDR Report Key: 7944689
• MDR Text Key: 123066047
• Report Number: 3011706110-2018-00213
• Device Sequence Number: 1
• Product Code: GXH
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ATRICURE CRYO PEN (UNKNOWN)
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2018
• 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): Disability