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

Model Number PRO145

Device Problem Device Handling Problem (3265)

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

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

Case-(b)(4) the pro145 device lot number 90847 was returned and visual and functional evaluated.The complaint was confirmed to show difficulty of deployment of the clip.

Event Description

It was reported on (b)(6) 2019, that a patient underwent a minimally invasive mitral valve repair and a left atrial appendage management procedure.When the surgeon was releasing the pro145 atriclip, the orange button did not pull properly.The surgeon experienced some difficulty but was able to place the clip on the appendage.The procedure was prolonged for five minutes with the care of the patient and procedure outcome not being affected.There was no 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 ; 5137554563
• MDR Report Key: 9086912
• MDR Text Key: 159515210
• Report Number: 3011706110-2019-00043
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: PRO145
• Device Catalogue Number: A000826-1
• Device Lot Number: 90847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2019
• 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