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 PRO235

Device Problem Difficult to Remove (1528)

Patient Problem Perforation (2001)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Case-(b)(4).The pro235 atriclip device was not returned for evaluation, but a device history review was obtained for lot number 103803.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

It was reported on (b)(6) 2020 that a patient underwent a convergent epicardial ablation and left atrial appendage (laam) management procedure.During laa portion of the clip placement procedure the atriclip pro235 was unable to be deployed at the position the surgeon had intended.The surgeon attempted to pull the clip out and during attempt to remove the clip the device caught a corner of the appendage causing laa tear and bleeding.The surgeon used snow and floseal to stop bleeding and stabilized the patient.Post-operatively the patient was doing well.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• 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
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 10734669
• MDR Text Key: 213044451
• Report Number: 3011706110-2020-00032
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160454
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: PRO235
• Device Catalogue Number: A000965
• Device Lot Number: 103803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2020
• 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: EPI-SENSE
• Patient Outcome(s): Life Threatening; Required Intervention