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 Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/15/2018

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 cryo2 device was not reported or able to be subsequently ascertained.The complaint could not be confirmed.

Event Description

It was reported that on (b)(6) 2018 a (b)(6) female patient underwent an atrial septal defect repair (asd) and was enrolled into the (b)(6) clinical study.The intercostal cryoanalgesia procedure was performed per protocol.The patient complained of hyperesthesia that began on (b)(6) 2018.During the 90-day post procedure follow-up visit it was determined that the patient did not require an in-office pain sensitivity assessment.At the 180 days follow up visit on (b)(6) 2018, the patient still complained about having pain sensitivity in the area around the surgical incision site.This event is a procedure related complication.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: 7943496
• MDR Text Key: 123059930
• Report Number: 3011706110-2018-00212
• 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: CRYO2
• Device Catalogue Number: A000683
• Device Lot 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
• Patient Age: 45 YR
• Patient Weight: 67