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

Model Number	COOLRAIL LINEAR PEN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Sepsis (2067)
Date of Event	10/19/2021
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3011706110-2021-00053
• Device Sequence Number: 4906401
• Product Code: OCL
• UDI-Device Identifier: 00818354010893
• UDI-Public: 00818354010893
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K190587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLL2, MLP1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male