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

Model Number OLL2

Device Problem Failure to Conduct (1114)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

Complaint # (b)(4).The device was not returned for evaluation, however, the dev ice history record was reviewed and no non-conformance or reworks were noted during the manufacturing process that relate to the reported issue.Device was discarded by account.

Event Description

It was reported during avr and pvi procedure, during right pulmonary vein isolation transmurality was not achieved for 3 times and the conductance-line in display did not move for over 40 seconds, ablation lines were made.At this time, no error code was displayed.For the left pvi transmurality was achieved the second time.The operation was completed, then the bleeding was noticed from postoperative drain.A re-thoracotomy was conducted.The bleeding part was suspected the position from pvi, but not from it.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ATRICURE SYNERGY ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040 3886
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040-3886 ; 5137555328
• MDR Report Key: 5968312
• MDR Text Key: 55315078
• Report Number: 3003502395-2016-00123
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 61640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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