MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

Model Number	PRO235
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 a patient underwent a minimally invasive epicardial surgical left ventricular lead placement with concomitant left atrial appendage (laa) exclusion.The pro235 atriclip was placed and the distal tip of the left atrial appendage (laa) was excised.After excision of the tip of the laa, pulsatile bleeding was observed.A 45mm endo stapler was then used to close the laa.Bleeding was stopped and patient left the operating room in stable condition.This was a procedural complication and there was no reported device malfunction.
Additional Manufacturer Narrative
(b)(4) the product history record was reviewed for lot 116878.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
• Common Device Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
• 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 45040 ; 5136448220
• MDR Report Key: 15122247
• Report Number: 3011706110-2022-00026
• Device Sequence Number: 20234270
• Product Code: PZX
• UDI-Device Identifier: 30840143900178
• UDI-Public: (01)30840143900178(17)250101(10)116878
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/28/2022

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: 01/01/2025
• Device Model Number: PRO235
• Device Catalogue Number: A000965
• Device Lot Number: 116878
• 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: 06/28/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 45MM ENDO STAPLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown