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

Model Number	PRO245
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the pro240 device was not returned for evaluation, but a device history review was obtained for lot number 104849.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.
Event or Problem Description
On (b)(6) 2022 a 65-year-old male patient underwent a stand alone robotic left atrial appendage (laa) exclusion procedure.The pro245 clip was placed and closure of the laa was confirmed.As the surgeon was pulling the applicator back, bleeding was observed.The procedure was converted to a sternotomy and a perforation was discovered of a cardiac vein that was medial to the base of the laa.The perforation was repaired with a 4-0 prolene suture.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• 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: 15209733
• Report Number: 3011706110-2022-00027
• Device Sequence Number: 17298804
• Product Code: PZX
• UDI-Device Identifier: 00818354015058
• UDI-Public: (01)00818354015058(17)230801(10)104849
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/11/2022

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: 08/01/2023
• Device Model Number: PRO245
• Device Catalogue Number: A000967
• Device Lot Number: 104849
• 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: 07/15/2022
• Initial Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 65
• Patient Sex: Male