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 Problem Death (1802)

Event Date 07/28/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).No device returned.No evaluation could be performed.No reported device malfunction during the procedure.

Event Description

On (b)(6) 2017, a male patient received a deep style staged minimally invasive thoracoscopic ablation procedure with laa closure, using a coolrail linear pen (mcr1), an ablation system and an laa clip.The patient was off pump and not heparinized.It was reported that the patient was still in the hospital recovering on post-op day 4 when the patient had a bowel perforation that required surgery to repair.While in icu recovering from the surgery for the bowel perforation, the patient expired from aspiration.The patient expired on (b)(6) 2017.No autopsy was performed.It was reported that the patient had a bowel perforation 6 months earlier which was surgically repaired, after having back surgery.The bowel perforation from this recent procedure was attributed to the anesthesia.No device malfunctions or procedural issues were reported during the initial procedure.

• 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: anupam bedi
• MDR Report Key: 6865685
• MDR Text Key: 86156505
• Report Number: 3011706110-2017-00083
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care 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: 08/24/2017
• 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: Initial
• Patient Sequence Number: 1
• Treatment: EMR1, EML2, PRO2, MID1, AND MAX5
• Patient Outcome(s): Death