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 Arrhythmia (1721)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation; however, the device history review was reviewed for lot number 70820 and no non-conformance or reworks were noted during the manufacturing process that relate to the reported issue.

Event Description

A (b)(6) year-old-female patient underwent a full maze procedure prior to (b)(6) 2017.There were no reported procedural complications, post procedure, the patient was implanted with a pacemaker.The surgeon indicated the possibility that when he ablated svc line, he also ablated sinus node.The surgeon stated that the width of ablation effective area was wider than a probe, so the ablation might have had some influence on the sinus node.The patient is in stable condition.There were no reported 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: 7549940
• MDR Text Key: 109424662
• Report Number: 3011706110-2018-00167
• 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,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: CRYO2
• Device Catalogue Number: A000683-JP
• Device Lot Number: 70820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2017
• 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): Required Intervention
• Patient Age: 70 YR