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

Model Number MCR1

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

Patient Problems Stroke/CVA (1770); Death (1802); Perforation of Esophagus (2399)

Event Date 11/02/2011

Event Type  Injury  

Manufacturer Narrative

Case (b)(4).The device was not returned for evaluation but a device history review was obtained for lot number 31314.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

Event Description

On (b)(6) 2011 a (b)(6) male underwent a deep procedure as part of being enrolled into the deep hybrid study with clip placement.The hospitalization was uneventful and there were no reports of adverse events.On post-op day 27, (b)(6) 2011, the patient experienced a "neurological deficit".Patient was unconscious for 1.5 hrs, reported having slurry speech, shortness of breath and weakness.Patient was hospitalized for further testing.Mri showed numerous acute infarcts present throughout the brain.Medical records indicated that patient had anemia with black stools.There was no ct/mr imaging of the esophagus nor biopsy was performed in the case.The subject was placed in hospice and made dnr after the stroke.Subject expired on (b)(6) 2011.As part of the study, the case was adjudicated and it was deemed by the adjudicator that atrio-esophageal fistula was highly unlikely.This event has previously been reported to the agency under ide study (b)(4).This event has been adjudicated as a procedural issue as part of the ide study (b)(4).Although this event has not been attributed to the device, atricure is reporting this event under part 806.

• 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 ; 5137554563
• MDR Report Key: 7802575
• MDR Text Key: 117791288
• Report Number: 3011706110-2018-00205
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122611
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCR1
• Device Catalogue Number: A000475
• Device Lot Number: 31314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2011
• 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: ATRICLIP,EMR2,EML2,MAX5
• Patient Outcome(s): Death
• Patient Age: 67 YR