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 Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

The device was received and sent to atricure's engineering department for analysis.The devise was examined and test, and was found to meet all required specifications.The complaint could not be confirmed.

Event Description

It was reported that during an open standalone procedure, an oll2 device was used to create seven successful ablations for right pulmonary vein isolation.After the ablations, a blood drain tube was installed under the beating heart.The surgeon then performed six ablations to isolate the left pulmonary veins.After the last 40 second ablation of the left pulmonary vein, the surgeon noticed bleeding along the ablation line.The bleeding was stopped by using felt, and the operation completed.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ISOLATOR SYNERGY CLAMP, LONG JAW
• Manufacturer (Section D): ATRICURE, INC.; 6217 centre park dr.; west chester OH 45069 3886
• Manufacturer Contact: john huff ; 6217 centre park dr; west chester, OH 45069-3886 ; 5136444725
• MDR Report Key: 5090992
• MDR Text Key: 26284009
• Report Number: 3003502395-2015-00035
• Device Sequence Number: 1
• Product Code: OCL
• 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: company representative
• Reporter Occupation: Service Personnel
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 57668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2015
• 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): Required Intervention