MAUDE Adverse Event Report: ATRICURE, INC. SOFTIP GUIDE CANNULA

Model Number	SOFTIP GUIDE CANNULA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) - the device was not returned for investigation and no device malfunction was alleged.A review of the production records indicates that the devices were released with no non-conformances that would contribute to the event.
Event or Problem Description
On (b)(6) 2023 a patient underwent a left atrial appendage management procedure utilizing the lariat suture device with concomitant convergent procedure.The softip guide cannula was passed without a guidewire in place through the pericardial window.During placement, the right ventricle was punctured.Procedure was converted to an open chest procedure via median sternotomy and the injury was repaired with sutures.Patient was stable and the convergent procedure was completed.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: SOFTIP GUIDE CANNULA
• Common Device Name: SOFTIP GUIDE CANNULA
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH ; 5136448220
• MDR Report Key: 16400672
• Report Number: 3011706110-2023-00008
• Device Sequence Number: 20232106
• Product Code: GAT
• UDI-Device Identifier: 30840143903698
• UDI-Public: (01)30840143903698(17)230501(10)P1232A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: SOFTIP GUIDE CANNULA
• Device Catalogue Number: FG-0008-02
• Device Lot Number: P1232A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Female
• Patient Weight: 110 KG