MAUDE Adverse Event Report: ATRICURE, INC. COOLRAIL LINEAR PEN; SURGICAL DEVICE, ABLATION CARDIAC

Model Number MCR1

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

Patient Problems Air Embolism (1697); Death (1802); Fistula (1862)

Event Type  Death  

Event Description

The pt underwent a total thoracoscopic surgery, that the surgeon said went perfectly.No medical device malfunctions or injuries were noted during the surgery.The pt was discharged from the hosp, and was doing well at home post op.The pt reported feeling better than she had in years.Approximately 30 days post op, the pt's health began to deteriorate and she was hospitalized.She was diagnosed with a neurological injury to the brain.At that point, she was transferred back to the leuven univ hosp.Less than a day after her admission, she passed.An autopsy and an pathology analysis revealed an atrial esophageal fistula, approximately 0.7 cm, in the middle of the left posterior atrium wall, which was not in close proximity of the device usage.The pt also had a septum closure endocardial device implanted prior to the surgery.The actual cause of the fistula is unk.

Manufacturer Narrative

(b)(4).The device was not returned to atricure for eval and disposed of by the hosp.

• Brand Name: COOLRAIL LINEAR PEN
• Type of Device: SURGICAL DEVICE, ABLATION CARDIAC
• Manufacturer (Section D): ATRICURE, INC.; west chester OH
• Manufacturer Contact: john huff ; 6217 centre park dr; west chester, OH 45069 ; 5136444725
• MDR Report Key: 4797704
• MDR Text Key: 15571858
• Report Number: 3003502395-2015-00018
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCR1
• Device Catalogue Number: A000475
• Device Lot Number: 526113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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; Hospitalization
• Patient Age: 65 YR
• Patient Weight: 45