MAUDE Adverse Event Report: ATRICURE INCORPORATED ATRICLIP; CLIP, IMPLANTABLE

Lot Number 107640

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/13/2022

Event Type  Injury  

Event Description

Atriclip would not close securely around the appendage.Fda safety report id# (b)(4).

• Brand Name: ATRICLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ATRICURE INCORPORATED; mason OH 45040
• MDR Report Key: 14776247
• MDR Text Key: 294617719
• Report Number: MW5110421
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 107640
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American