MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE ATRICLIP FLEX; CLIP, IMPLANTABLE

Lot Number	101840
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon evaluated atrial appendage clip for use during surgery.He noticed that the [invalid] in the clip were too loose and requested another atrial appendage clip.The substitute atrial appendage clip worked appropriately and there was no further incident.There were no complications noted during surgery and the patient was admitted to the icu for post operative cardiac care.Fda safety report id# (b)(4).

• Brand Name: ATRICURE ATRICLIP FLEX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): ATRICURE, INC.; mason OH 45040
• MDR Report Key: 10224101
• Report Number: MW5095341
• Device Sequence Number: 14238669
• Product Code: FZP
• UDI-Device Identifier: 00818354014525
• UDI-Public: (01)00818354014525
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2023
• Device Lot Number: 101840
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 126