MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP LAA EXCLUSION SYSTEM; CLIP, IMPLANTABLE

Model Number ACH135

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2022

Event Type  malfunction  

Event Description

Atricure atriclip, lot# 117928, ref# ach135 malfunctioned during procedure.No patient harm.It breaks when i tried to adjust the device which should not happen and was ok with the second one.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 15787617
• MDR Text Key: 303546260
• Report Number: 15787617
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2022

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 Model Number: ACH135
• Device Catalogue Number: A000688
• Device Lot Number: 117928
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1