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 PRO250

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The atriclip pro250 device lot number 96782 was returned for evaluation and was visually and functionally tested.The complaint was confirmed for articulation movement failure and difficulty in deployment.

Event Description

It was reported that on (b)(6) 2020 during an off-pump thoracoscopic ablation with left atrial appendage management (laam) procedure, the surgeon placed a pro250 and confirmed clip placement by transesophageal echocardiogram (tee).When the surgeon went to deploy the clip by pulling the orange tab, it seemed jammed and the clip would not release from the handle.At that point, the surgeon decided to use an endoscopic scissor to cut and release the clip.There was no reported procedural complication or adverse consequence to the patient.

• 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: 9844886
• MDR Text Key: 195177311
• Report Number: 3011706110-2020-00010
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: PRO250
• Device Catalogue Number: A000968
• Device Lot Number: 96782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2019
• 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