MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE SYNERGY ABLATION SYSTEM

Model Number OSL2

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

Patient Problem Perforation (2001)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was returned and visually and functionally tested.The device met all criteria and functioned normally.The complaint could not be confirmed.There was no report of any device malfunctions.

Event Description

On (b)(6) 2018 a (b)(6) female patient underwent a on-pump avr/pvi/ascending procedure.The surgeon used an osl2 and performed 4 ablations and cleaned the clamp in between each ablation.At the end of the ablations, the surgeon found a hole near where the clamp had been used near the left pv at the end of the case.There was bleeding that was controlled by suture but did not necessitate a transfusion.Patient was fully heparinized and the procedure was prolonged 20 minutes.Post- procedure patient outcome was good.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ATRICURE SYNERGY ABLATION SYSTEM
• 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: 7503022
• MDR Text Key: 107870670
• Report Number: 3011706110-2018-00161
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100046
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 08/01/2018
• Device Model Number: OSL2
• Device Catalogue Number: A000432
• Device Lot Number: 67706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2016
• 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
• Patient Age: 52 YR
• Patient Weight: 87