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

Model Number OLL2

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

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

Event Date 06/03/2016

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 reworks were noted during the manufacturing process that relate to the reported issue.Device discarded by facility.

Event Description

It was reported that during mvr, tap and maze, on-pump and beating, the first lpvi was not able to get transmurality and conducting stopped in 40 seconds.On the same position, conducting again, could not get transmurality in 20 seconds.Therefore, the conducting position was moved a little, the conducting was completed in 20 seconds at this time.The clamp was released and removed, bleeding was observed.The bleeding position was at lipv side on pvi line, sized 2cm.Although suturing from out, patient's tissue was ruptured.Therefore, biological adhesive-sheet and hemostatic material was applied.Also, cutting in left atria and did mattress suture from inside.They stopped the bleeding.The surgeon commented that the operation procedure was as usual and there was no tension in ablation part.After the operation, the patient is recovering without any issue at this time.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ATRICURE SYNERGY ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: ranjana iyer ; 6217 centre park drive; west chester, OH 45069-3886 ; 5137555320
• MDR Report Key: 5797823
• MDR Text Key: 49631863
• Report Number: 3003502395-2016-00061
• 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: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• 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: 60646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2016
• 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