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

Model Number ACH240

Device Problem Misfire (2532)

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

Event Date 10/15/2020

Event Type  malfunction  

Event Description

While surgeon was using the atriclip device, it fired before he was in the chest of the patient.Since the atriclip is a single use device, a new one was obtained and used.

• 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: 10778132
• MDR Text Key: 214344728
• Report Number: 10778132
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ACH240
• Device Catalogue Number: A000917
• Device Lot Number: 103615
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA