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

Model Number	PROV50
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) the prov50 device, lot number 115672, was not returned for evaluation; however, the device history record was reviewed and no non-conformance or reworks were noted during the manufacturing process that relate to the reported issue.
Event or Problem Description
On (b)(6) 2022, a patient underwent an off-pump, left atrial appendage management (laam) surgical procedure.The physician placed a prov50 clip, but the clip was not deployed at base of laa per tee multiangle view.The physician readjusted the clip position and bleeding was observed near the laa.The cause of the bleed was undetermined and the physician noted that the patient had friable tissue.The bleeding did not stop post clip deployment, so the physician performed a sternotomy.Surgeon placed a second prov50 on the base of the laa under direct visualization to control bleeding.The bleeding slowed but did not stop, so patient was put onto cpb to get hemostasis.The bleed was repaired and hemostasis was achieved.The patient was stable post-procedure.This was a procedural complication with no reported device malfunctions.

• 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: 14292447
• Report Number: 3011706110-2022-00013
• Device Sequence Number: 5525070
• Product Code: PZX
• UDI-Device Identifier: 30840143900246
• UDI-Public: 30840143900246
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K210293
• 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): 05/04/2022

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: 11/01/2024
• Device Model Number: PROV50
• Device Catalogue Number: A000974
• Device Lot Number: 115672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2022
• 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: PROV50
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male