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

Model Number COOLRAIL LINEAR PEN

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

Patient Problems Fistula (1862); Sepsis (2067)

Event Date 10/19/2021

Event Type  Death  

Manufacturer Narrative

(b)(4) the mcr1 device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the mcr1 device was not reported or able to be subsequently ascertained.

Event Description

It was reported that on (b)(6) 2021 a male patient received an open, concomitant atrial valve replacement with an ablation for the left atrial box lesion set.The case completed with no procedural or device complications.2 weeks post-op, the patient was still healing well with no complications.Approximately 4 weeks post-op on (b)(6) 2021, the patient presented to the emergency room after an episode of dizziness and unconsciousness.He was transferred to another facility where the patient ultimately expired.Autopsy revealed an atrio-esophageal fistula in the region of the left atrial roof lesion.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: COOLRAIL LINEAR PEN
• Type of Device: COOLRAIL 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: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 12923500
• MDR Text Key: 281661140
• Report Number: 3011706110-2021-00053
• Device Sequence Number: 1
• Product Code: OCL
• UDI-Device Identifier: 00818354010893
• UDI-Public: 00818354010893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: COOLRAIL LINEAR PEN
• Device Catalogue Number: A000475
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• 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
• Treatment: OLL2, MLP1
• Patient Outcome(s): Death
• Patient Sex: Male