MAUDE Adverse Event Report: ATRICURE, INC. EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX; 3CM GUIDED COAG DEVICE GEN 4

Model Number CSK-1413

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

Patient Problem Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to atricure for evaluation and disposed of by the hospital.The lot number of the device was unable to be ascertained and there was no indication of a device defect or malfunction.Device discarded, no malfunction.

Event Description

Post-op sub-x convergent procedure, patient had a routine echocardiogram and was diagnosed with a large pericardial effusion.The patient was asymptomatic, vitals were stable.The patient's pericardium was tapped, 800cc of serosanguinous fluid had to be drained.The patient stated that she was having diarrhea and stopped her coltracine without consulting her doctor.Patient is doing fine and is still in nsr.

• Brand Name: EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX
• Type of Device: 3CM GUIDED COAG DEVICE GEN 4
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555320
• MDR Report Key: 6118988
• MDR Text Key: 60622302
• Report Number: 3003502395-2016-00165
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2016

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
• Device Operator: Health Professional
• Device Model Number: CSK-1413
• Device Catalogue Number: CSK-1413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR