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 PRO245

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

Patient Problem Perforation (2001)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

Case (b)(4).The pro245 device, lot number 91855 was returned for evaluation and was visually and functionally tested.The device was returned with the clip deployed and neither the clip nor the deployment cables were returned.The device was fully conforming and passed all functional testing.

Event Description

It was reported that on (b)(6) 2020 a (b)(6) year-old female with history of 2 prior ablations underwent a minimally invasive heparinized convergent and left atrial appendage management (laam) procedure.Once the convergent procedure was completed a standard port was placed for laam.The clip placement was challenging due to patient habitus.Laa was noted to be big, a sizing tool was used for laa measurement (40 cm) and the surgeon choose to upsize to pro245.Clip was inserted, rip cord was removed to deploy, separation was not well observed due to tightness of space.The clip was deployed but the handle got stuck in the port.The surgeon observed through port camera arterial blood pooling.A sternotomy was performed, a pin size hole on the left atrium behind appendage was identified.The bleed was managed, clip was removed and a new clip pro245 was successfully placed.A cryo device was used to complete right sided lesions and for pulmonary vein isolation.Patient successfully came off pump.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 innovaton way; mason, OH 45040 ; 5136448220
• MDR Report Key: 9744196
• MDR Text Key: 189327059
• Report Number: 3011706110-2020-00006
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: PRO245
• Device Catalogue Number: A000967
• Device Lot Number: 91855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• 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
• Patient Age: 56 YR