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 Death (1802); Renal Failure (2041)

Event Date 02/19/2018

Event Type  Death  

Manufacturer Narrative

(b)(4): the device had been discarded by the facility.There was no product history review as no lot or serial information was provided for the device.There was no reported device malfunction during the procedure.

Event Description

On (b)(6) 2018, a (b)(6)-year-old, female patient received an off-pump convergent ablation procedure with laa exclusion via subxiphoid approach using an epi-sense guided coagulation system.The patient was cardioverted after the procedure.The electrophysiologist performed a lariat procedure to exclude the laa and a tee confirmed placement.The patient¿s status was fine peri- and post-operatively.The patient was reportedly stable and in recovery over the weekend with a standard post-operative care plan.There were no reported renal complications prior to (b)(6) 2018 or over the weekend prior to (b)(6) 2018.On (b)(6) 2018, the electrophysiologist observed that the patient¿s creatinine levels were elevated.It was reported that the patient died on (b)(6) 2018 from renal failure.There were no reported device malfunctions or procedural complications during the initial procedure.

• 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: 7339919
• MDR Text Key: 102439599
• Report Number: 3011706110-2018-00137
• 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: 03/14/2018

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: CDK-1413
• 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: 02/21/2018
• Initial Date FDA Received: 03/14/2018
• 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
• Patient Age: 75 YR