MAUDE Adverse Event Report: ATRICURE, INC. MULTIFUNCTIONAL LINEAR PEN

Model Number MLP1

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.No device malfunction was reported.

Event Description

A patient had a standard thorascopic maze/bilateral pv isolation with mlp1 and endoclamp in (b)(6) 2016 with no procedural difficulties/complications post procedure and was discharged the next day.One month post-op, the patient was seen in the clinic for follow up and was well but 2 days later, the presented to a local hospital with meningeal symptoms and then was discharged home and re-presented a few days later and was admitted.The patient had a subsequent fit and cardiac arrest.The patient was transferred back to (b)(6) and was diagnosed with phlegmon in the la where he was taken back to the theatre where a patch was put to the back of the la with endoscopy and while the aorta was cross clamped, a 1cm healed tear in the esophagus was seen.The patient left with a neurological deficit which continued through recovery which was a slow recovery.A few months later the patient was admitted with sepsis from which he did not recover from.The exact date of death was unable to be obtained from surgeon and the cause of death will be determined during an inquest.

• Brand Name: MULTIFUNCTIONAL LINEAR PEN
• Type of Device: MULTIFUNCTIONAL LINEAR PEN
• 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: 6986441
• MDR Text Key: 90517957
• Report Number: 3011706110-2017-00094
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130521
• 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
• Report Date: 10/30/2017

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: MLP1
• Device Catalogue Number: A00318
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/30/2017
• 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: N
• Patient Sequence Number: 1
• Treatment: ENDOCLAMP
• Patient Outcome(s): Death