MAUDE Adverse Event Report: ATRICURE, INC. NCONTACT CANNULA ACCESSORY; CANNULA ACCESSORY TO COAGULATION DEVICE

Model Number CANNULA

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

Patient Problems Death (1802); Great Vessel Perforation (2152)

Event Date 03/28/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation as there was no indication of a device defect or malfunction.It was a reported adverse event and the product was discarded by the facility.

Event Description

On-pump, subxiphoid epicardial ablation procedure using the episense ablation device.During the subxiphoid pericardial window creation, there was attempted insertion of the cannula into the pericardial window and within 10 minutes into the procedure, the physician observed bleeding.It was speculated that there was a tear in the inferior vena cava and the procedure was converted to an emergency open sternotomy.No device malfunction was noted.The patient was placed on extracorporeal membrane oxygenation (ecmo).Patient was obese, (b)(6) pounds and 4'10".It was stated later during follow up conversation with the facility that the cause for the bleed was unknown.The patient was removed from ecmo support and is stable.Additional av node ablation has been performed using cryo and a permanent pacemaker is scheduled for this patient.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.There was no reported device malfunction during the initial procedure.The patient passed away due to sepsis on (b)(6)2017.

Event Description

Updated patient status: on (b)(6) 2017, this patient passed away; the cause of death was sepsis.This was reported to atricure by the surgeon on 10/10/2017.

• Brand Name: NCONTACT CANNULA ACCESSORY
• Type of Device: CANNULA ACCESSORY TO COAGULATION DEVICE
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; cincinnati OH 45040 0000
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; cincinnati, OH 45040-0000 ; 5137555328
• MDR Report Key: 6523130
• MDR Text Key: 73782451
• Report Number: 3011706110-2017-00041
• 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
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CANNULA
• Device Catalogue Number: CSK-6130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 91