MAUDE Adverse Event Report: ATRICURE INC. ATRICURE SYNERGY ABLATION SYSTEM; ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, LONG JAW

Model Number OLL2

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

Patient Problem Great Vessel Perforation (2152)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) the device was returned for evaluation and visually and functionally tested pursuant to qrf-0305.C.The device met all criteria and functioned normally.The complaint could not be confirmed.

Event Description

Mitral valve repair/replacement-maze-possibly tricuspid valve repair open sternotomy.During the maze procedure, the surgeon ablated the left pulmonary veins 6 times.Then, using their own pacing forceps, tested for isolation, it was noted veins were not isolated.He then ablated 6 more times and again was unable to gain isolation of the left pulmonary veins.At this time, when the surgeon lifted up the left side of the heart to look at the left pulmonary veins, he noticed a hole at one of his ablation lines on the pv.At this time he arrested the heart and completed the maze procedure.After completing the exclusion of the left atrial appendage and the connecting lesion to the superior left pulmonary vein, he then ablated the left pulmonary veins 2 more times.After completing the maze he then repaired the hole in the left pulmonary veins at the ablation line.Surgeon's complaint was that he felt that the clamp or algorithm of the asu was not working right.The same clamp was used for the entire case and good lesions were achieved on all other parts of the maze procedure.Over ablating the left pulmonary veins could have damaged tissue and caused the hole in the ablation line.Patient was on pump and heparinized.The case was delayed by ten to fifteen minutes.Surgeon completed maze, repaired hole in left pulmonary vein, completed mvr and tvr.Clamp was cleaned after every 6th ablation.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ISOLATOR SYNERGY SURGICAL ABLATION SYSTEM OPEN, LONG JAW
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555328
• MDR Report Key: 6290301
• MDR Text Key: 66176042
• Report Number: 3003502395-2017-00020
• 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: Physician
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/01/2019
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 69612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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: 62 YR