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

Model Number OLL2

Device Problem Insufficient Information (3190)

Patient Problem Excessive Tear Production (2235)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation, however, the device history record was reviewed and no non-conformance or re-works were noted during the manufacturing process that relate to the reported issue.The device was discarded by customer.

Event Description

It was reported during a mitral valve replacement / maze procedure, while manipulation of the pulmonary veins to perform isolation, a tear in the right atrium was observed.The surgeons repaired the tear and the procedure continued without incident.The surgeon stated at the end of the case that she did not feel that the normal operation of the clamp contributed to the tear.There were no indications of a device malfunction.This is being reported as a procedural complication.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ISOLATOR SYNERGY CLAMP LONG JAW
• Manufacturer (Section D): ATRICURE INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer (Section G): ATRICURE INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: john huff ; 6217 centre park drive; west chester, OH 45069-3886 ; 5136444725
• MDR Report Key: 5125273
• MDR Text Key: 27430034
• Report Number: 3003502395-2015-00037
• Device Sequence Number: 1
• Product Code: OCL
• 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
• Reporter Occupation: Other
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/31/2015
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 58410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2015
• 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