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 Perforation (2001)

Event Date 11/10/2017

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 was not reported.There were no reported device malfunctions.

Event Description

On (b)(6) 2017, a patient underwent a mics/mvp/maze procedure from the endocardium side.At the time, the patient was being weaned from the ventilator, bleeding was noted from the laa and a decision was made to convert the procedure to a sternotomy.The bleeding had occurred while the surgeon was doing the cryoablation from the laa to the left superior pulmonary vein.The surgeon recognized that the bleeding was a technical error by sticking the laa with the cyro2.The laa was repaired and did not necessitate a transfusion.It was reported that there were no device malfunctions.

• 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: anupam bedi ; 7555 innovation way; mason, OH 45040
• MDR Report Key: 7529668
• MDR Text Key: 108754056
• Report Number: 3011706110-2018-00163
• Device Sequence Number: 1
• Product Code: GXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: CRYO2
• Device Catalogue Number: A000683-JP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2018
• 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): Life Threatening; Required Intervention