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

Model Number OLL2

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

Patient Problem Perforation (2001)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) the device was returned for evaluation and visually and functionally tested.The device met all criteria and functioned normally.

Event Description

On (b)(6) 2017, a (b)(6), male patient received a cabg/maze procedure via sternotomy and on-pump using an oll2 clamp and ablation system.While performing pulmonary vein isolation, the surgeon was getting transmural lesions on the right side and burned four (4) complete times.Once moving onto the other side, the surgeon positioned the clamp correctly on left veins and kept experiencing the clamp timing out and not getting a complete lesion.After four (4) attempts at ablating, the surgeon noticed bleeding and stated that the clamp had "tore the tissue on the veins".The bleeding was stopped with a stitch and a transfusion was not needed.The cabg procedure was completed, but the full bi-atrial maze procedure was not completed.The surgeon indicated that the bleeding was related to maneuvering around the difficult anatomy and that the tearing of the vein was a procedural complication based on a failure to remove the clamp prior to manipulation.The procedure was prolonged 6-7 minutes.No device malfunction was reported.

• 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
• MDR Report Key: 6913378
• MDR Text Key: 88118844
• Report Number: 3011706110-2017-00087
• 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: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 73383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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: 71