MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE BIPOLAR SYSTEM; ISOLATOR SYNERGY CLAMP LEFT CURVE

Model Number EML2

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

Patient Problems Death (1802); Blood Loss (2597)

Event Date 08/13/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Device not returned for evaluation however device history record reviewed and no non-conformance or re-work noted during manufacturing process that would be related to the reported issue.

Event Description

It was reported that during a mis procedure, that when the surgeon placed the clamp around the left pulmonary veins and closed the clamp, he noticed bright red blood.He opened the patient's chest to gain control of the bleeding.Surgeon thinks there must have been tissue attached to the left atrium that was also connected to the pulmonary vein.When he closed the clamp (eml), the left atrium compressed and the tissue connected to the left pa pulled enough to tear the pa.The surgeon massaged the heart while waiting for the perfusionist to set up the bypass pump.After getting the patient on pump and repairing the bleeding, the surgeon completed the left side of the maze procedure and applied a clip on the left atrial appendage.After completing the left pulmonary vein isolation, the patient was taken off pump, and the ablations were tested for isolation block.After isolation block was confirmed, the patient was taken to recovery.On (b)(6) 2015, atricure's director of procedural development stopped by the hospital to follow up on the patient.The surgeon informed him that the patient expired on 08/22/2015.

• Brand Name: ATRICURE BIPOLAR SYSTEM
• Type of Device: ISOLATOR SYNERGY CLAMP LEFT CURVE
• Manufacturer (Section D): ATRICURE, INC.; west chester OH
• Manufacturer Contact: john huff ; 6217 centre park dr.; west chester, OH 45069 ; 5136444725
• MDR Report Key: 5077653
• MDR Text Key: 25900530
• Report Number: 3003502395-2015-00034
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EML2
• Device Catalogue Number: A000467
• Device Lot Number: 58549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• 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): Death