MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX

Model Number CDK-1413

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

Patient Problems Stroke/CVA (1770); Perforation of Esophagus (2399)

Event Date 01/07/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the epi-sense device was not reported or able to be subsequently ascertained.The complaint could not be confirmed.

Event Description

It was reported that on (b)(6) 2018, a (b)(6) year-old male patient underwent a convergent procedure via a sub-x approach.Patient had a history of heart failure, with biv pacemaker, icd, with poor left ventricular function (ef 20-24%).He also presented with atrial fibrillation and it was hoped that restoration to sinus rhythm would improve his left ventricular function.He was placed on the lvad recipient list.No prior history of ablation procedures.Patient was heparinized during procedure, a tee was conducted, and no clot was found in left atrial appendage.A circa temperature probe was placed covering the heart in ap view.The surgeon performed total of 27 lesions, at each temperature spike, saline flush was delivered which brought the temperature back to the baseline.Since pericardium on the right had folds towards the ripv it was hard to create a lesion.Patient cardioverted into 1st degree av block.Ep did an endocardial map and was satisfied.On (b)(6) 2018 the patient was discharged.Patient was reviewed one week after discharge and his condition was unremarkable.On (b)(6) 2018 the patient presented to emergency room with bleeding from incision site, treated, and was discharged on (b)(6) 2018.Two and a half weeks post discharge the patient was readmitted to another hospital with tingling and numbness in his upper limbs.He had a ct scan without contrast which was inconclusive.The patient was transferred to (b)(6) hospital where he had a repeat ct scan which revealed air in the pericardium and an oesophagoscopy which revealed an oesophageal injury.During a barium swallow investigation, the patient suffered another stroke.The patient was immediately taken to the operating theatre where a thoracotomy was performed.At operation an atrio-oesophageal fistula was discovered.The breach in the left atrium was closed with sutures and the oseophageal section of the fistula was closed over a ¿t¿ tube stent.The patient was returned to the intensive care unit after the thoracic exploration.As of (b)(6) 2019 patient is still in icu, tolerating the tube feedings and trach collar, and is having moments of alertness.There was no report of any device malfunction during the procedure.

Manufacturer Narrative

(b)(4) new information was obtained from facility that on (b)(6) 2019 patient became unresponsive and hypotensive, cpr and acls were performed, patient expired: 9:55pm.

• Brand Name: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Type of Device: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 8283338
• MDR Text Key: 134359839
• Report Number: 3011706110-2019-00007
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K142084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CDK-1413
• Device Catalogue Number: CDK1413
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR