MAUDE Adverse Event Report: ATRICURE INC. ATRICURE SYNERGY ABLATION SYSTEM; ISOLATOR SYNERGY CLAMP LONG JAW

Model Number OLL2

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

Patient Problem Atrial Perforation (2511)

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not yet been returned to atricure for evaluation.If additional information is received a supplemental report will be submitted.

Event Description

It was reported that during a concomitant aortic valve replacement procedure, transmurality on the unit was not recognized when tissue had been ablated.The surgeon stated after performing many ablations it kept going to 30 seconds.By doing so many ablations and the machine not recognizing when transmurality was complete, a hole in the atrium was formed and bleeding had begun once by-pass was reversed.The tear was closed with a bovine pericardial patch and the procedure completed.The patient made an uneventful recovery thereafter with no long term adverse consequence.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ISOLATOR SYNERGY CLAMP 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: 6091418
• MDR Text Key: 59554224
• Report Number: 3003502395-2016-00158
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: D152172
• 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: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• 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: A00362
• Device Lot Number: 60789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: (B)(4); (B)(4)
• Patient Outcome(s): Life Threatening; Required Intervention