MAUDE Adverse Event Report: ATRICURE, INC ATRICLIP IMPLANT DEVICE; CLIP, IMPLANTABLE

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 05/07/2021

Event Type  malfunction  

Event Description

Defective atriclip implant device reference # ach245 (atricure) will open clip but not activate implant clip.Fda safety report id # (b)(4).

• Brand Name: ATRICLIP IMPLANT DEVICE
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ATRICURE, INC
• MDR Report Key: 11831415
• MDR Text Key: 251364111
• Report Number: MW5101366
• Device Sequence Number: 1
• Product Code: FZP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1