MAUDE Adverse Event Report: ATRICURE, INC. NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX

Model Number CSK-023

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

Patient Problems Death (1802); Perforation of Esophagus (2399)

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 was not reported.There was no reported device malfunction.Multiple attempts have been made unsuccessfully by atricure to obtain follow-up information from the surgeon such as date of occurrence and detailed procedure information.

Event Description

It was reported by a surgeon on (b)(6) 2018, during a conference in milan, "the convergent approach combining forces for persistent af: novel approach in hybrid terms" early on convergent cases while using epi-sense device one of his patients had experienced an atrio-esophageal fistula and later, the patient expired.

Manufacturer Narrative

(b)(4).Device stated in original narrative the product code #/ device name was incorrect.The complaint is against the device numeris tethered coagulation system with visitrax, product number csk-023 ¿ 510k number - k082203.Information was limited and through research, this information only just came to light.

• Brand Name: NUMERIS TETHERED COAGULATION SYSTEM WITH VISITRAX
• Type of Device: NUMERIS TETHERED 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: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5137554563
• MDR Report Key: 8066620
• MDR Text Key: 127048240
• Report Number: 3011706110-2018-00218
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K082203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSK-023
• Device Catalogue Number: CDK-1413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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