MAUDE Adverse Event Report: ATRICURE, INC. ISOLATOR SYNERGY CLAMP; ELECTROSURGICAL CUTTING/COAGULATION

Model Number EMR2

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hernia (2240)

Event Date 01/12/2015

Event Type  Injury  

Event Description

It was reported that following a minimally invasive, stand-alone maze on a male patient, approximately 2-3 hours post-operatively the patient had to be taken back into the operating room.A mini-thoracotomy was performed and it was noted that the heart had herniated over the right-side pericardium.It was reported that the pericardium had not been closed in the original procedure which is standard.The surgeon placed the patient on bypass, emptied the heart and was able to correct the condition.Patient's current condition is not yet known.There was no indication of a device defect or malfunction.During review by atricure's medical director, this situation is believed to be caused by procedural complications, i.E.,the pericardium dissection was larger than expected, allowing the heart to pass through the dissection and herniate.Atricure devices were not used to dissect the pericardium.

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation as there was no indication of a device defect or malfunction.The situation is believed to be caused by procedural complications, i.E.The pericardium dissection was larger than expected, allowing the heart to pass through the dissection and herniate.Atricure devices were not used to dissect the pericardium.

• Brand Name: ISOLATOR SYNERGY CLAMP
• Type of Device: ELECTROSURGICAL CUTTING/COAGULATION
• Manufacturer (Section D): ATRICURE, INC.; west chester OH
• Manufacturer Contact: john huff ; 6217 centre park dr; west chester, OH 45069 ; 5136444725
• MDR Report Key: 4510183
• MDR Text Key: 5411687
• Report Number: 3003502395-2015-00010
• 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: 01/12/2015

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 Model Number: EMR2
• Device Catalogue Number: A000452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/10/2015
• 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): Required Intervention