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

Model Number ACH145

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

Patient Problem Perforation (2001)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation, however, a device history review was obtained for lot 94234.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) 2019 that a patient underwent a coronary artery bypass and left atrial appendage management procedure.An atriclip ach145 was placed successfully on the laa.As the surgeon was bringing the patient off bypass and the cross clamp was removed, there was blood observed below the clip filling the chest cavity.The patient was put back on bypass and the ach145 clip was removed.An atrial perforation was identified and the perforation was repaired using pledgets and sutures.The left atrial appendage was then removed and over sewn.This was a procedural complication, there was no reported device malfunction.

• Brand Name: ATRICURE ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
• Type of Device: ATRICURE 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: 9202246
• MDR Text Key: 162979642
• Report Number: 3011706110-2019-00048
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093679
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• 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: ACH145
• Device Catalogue Number: A000690
• Device Lot Number: 94234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2019
• 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): Life Threatening; Required Intervention