MAUDE Adverse Event Report: ATRICURE INC. MULTIFUNCTIONAL LINEAR PEN

Model Number MLP1

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

Patient Problems Death (1802); Fistula (1862)

Event Type  Death  

Manufacturer Narrative

(b)(4).The devices were not returned for evaluation, however the device history review was unable to be completed as the relevant device lot/serial number was not reported or able to be subsequently ascertained.The complaint could not be confirmed.Devices discarded by facility.

Event Description

A publication from august 2013 it was determined that a (b)(6) woman underwent bilateral minithoracotomy maze procedure off pump for treatment of symptomatic paroxysmal atrial fibrillation.During the procedure, pulmonary vein (pv) ablation was performed using a bipolar radiofrequency clamp.Linear bipolar radiofrequency ablation was also performed on the posterior left atrium (la) from the right to the left inferior pvs and from the right superior pv to the base of la appendage using the isolator transpolar pen.The procedure was seemingly unremarkable.However, the patient presented with new-onset seizures and left hemiparesis 3 weeks later; inr was 2.7.A head ct revealed cerebral pneumocephalus with air in the right frontal lobe the meninges, and the subarachnoid space.In addition, bubbles of air were seen in the subcutaneous tissues of the face and skull.Examination of the air pattern suggested an arterial distribution.In the interim, she developed acute, severe chest pain.An ecg showed new, large inferior st elevations consistent with acute myocardial injury.Ventricular fibrillation ensued, requiring cardiopulmonary resuscitation and external defibrillation.She subsequently underwent emergent cardiac catheterization, which revealed patent coronary arteries.A chest ct angiogram demonstrated an la-esophageal fistula.Air embolization to the brain resulting in seizures and neurologic injury, and to the right coronary artery (rca) resulting in acute myocardial infarction and cardiac arrest, was diagnosed.Emergent cervical esophageal diversion was performed.However, the hospital course was complicated by sepsis, metabolic acidosis, and hemodynamic compromise.The patient eventually expired.The presence of a large a-e fistula was later confirmed at autopsy.Although rare, fistula continues to remain an ominous and usually fatal complication of all af ablation strategies including even minimally invasive surgical ablation (mini-maze), as illustrated by this case.The a-e fistula in this patient likely resulted from esophageal thermal injury during linear radiofrequency ablation on the posterior la.Seizures, stroke, and/or signs of sepsis in the first few weeks following any type of af ablation should immediately raise suspicions about this catastrophic complication.

Manufacturer Narrative

A correction is being made to update suspect medical device.Complaints listed, (b)(4) (3003502395-2013-00003) and (b)(4) (3003502395-2016-00067) are all linked to the same complaint (b)(4), references a procedure done by dr.(b)(6).

• Brand Name: MULTIFUNCTIONAL LINEAR PEN
• Type of Device: MULTIFUNCTIONAL LINEAR PEN
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040 3886
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040-3886 ; 5137555320
• MDR Report Key: 5858276
• MDR Text Key: 51681919
• Report Number: 3003502395-2016-00067
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MLP1
• Device Catalogue Number: A000318
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2018
• 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; Other; Disability
• Patient Age: 55 YR