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

Model Number	PROV45
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 during a left atrial appendage (laa) exclusion procedure, t was noticed that the dacron was not completely covering the prov45 clip.An injury to the laa was observed.The patient was placed back on-pump and the procedure was converted to a sternotomy to repair the laa.An atriclip pro1 was placed on the the laa successfully.There were no additional patient complications reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the device was not returned for investigation however, the product history record was reviewed for prov45 lot number: 94661.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 PRO-V CLIP
• Common Device Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V 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: 14717573
• Report Number: 3011706110-2022-00020
• Device Sequence Number: 5074460
• Product Code: PZX
• UDI-Device Identifier: 00818354015140
• UDI-Public: 00818354015140
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191413
• 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,Followup
• Report Date (Section B): 08/15/2022

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: 06/01/2022
• Device Model Number: PROV45
• Device Catalogue Number: A000973
• Device Lot Number: 94661
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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: Unknown