MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE CLIP; ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE¿ CLIP

Model Number PRO140

Device Problem Difficult to Remove (1528)

Patient Problem Perforation (2001)

Event Date 11/19/2019

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2019 a patient underwent a minimally invasive mitral valve placement procedure with left atrial appendage management.The pro140 clip was placed and prior to removing the applier it was observed that tissue from the left atrium was caught in the gap of the deployment loop.The applier was removed and bleeding from the tissue on the left atrium was noted.The surgeon sewed the tissue by using a suture and stopped the bleeding.There was no delay in the case and no additional harm to the patient.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

Manufacturer Narrative

(b)(4) device was returned locked in articulation and in the open position.Neither the clip nor deployment cable were returned, indicating the clip had been deployed.The device passed all applicable visual and functional tests.The area between the loop and the tab of the yoke was examined under a microscope, there was tissue found in between the loop and the tab of the yoke.This provides evidence that the tissue had been pinched between the loop and the tab of the yoke.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE CLIP
• Type of Device: ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV COSGROVE¿ CLIP
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 9512193
• MDR Text Key: 176212935
• Report Number: 3011706110-2019-00062
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K122276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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 Expiration Date: 05/01/2022
• Device Model Number: PRO140
• Device Catalogue Number: A000825-3
• Device Lot Number: 94494
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention