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

Model Number EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS

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

Patient Problem Death (1802)

Event Date 02/27/2017

Event Type  Death  

Manufacturer Narrative

(b)(4) the device was not returned for evaluation.Device discarded by facility as there were no product complications or malfunctions.

Event Description

On (b)(6) 2017, a patient underwent a staged convergent procedure.Post-procedure, the patients¿ blood pressure remained unstable but the convergent procedure itself was unremarkable with no product malfunction encountered.The patient continued to experience a-fib post-procedure and on (b)(6) 2017, underwent the ep portion of the procedure and underwent extensive ablations.The procedure was completed without any complications and patient was anticoagulated with coumadin.On (b)(6) 2017, patient developed hemoptysis and was taken to icu where a ct scan performed ruled out perforation and fistula.The patient¿s condition worsened and he expired on (b)(6) 2017.The patient¿s other co-morbidities included cocaine abuse.There were no procedural complications or device malfunction noted.On (b)(6) 2017 detailing of events was communicated to the manufacturer.

• 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
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: anupam bedi
• MDR Report Key: 6835474
• MDR Text Key: 84268380
• Report Number: 3011706110-2017-00078
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2017

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: Other Health Care Professional
• Device Model Number: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS
• Device Catalogue Number: CDK-1413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 08/31/2017
• 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
• Treatment: CATHETER FOR EP ABLATION (NON-ATRICURE)
• Patient Outcome(s): Death
• Patient Age: 58 YR