MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ANASTOCLIP GC CLOSURE SYSTEM - VASCULAR & NEURO

Model Number	4008-06
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anastoclip gc medium clips were misfiring and then coming out of the vessel hanging/loose after being deployed.There were no patient injury.Two devices were involved in the event.
Additional Manufacturer Narrative
The device was not returned for evaluation.Therefore, we could not conclusively determine the root cause of the reported incident.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.Due to similar issues reported we have previously initiated a capa to further investigate the reported issue.Please note that this is report 1 of 2.Report 1220948-2023-00082 was submitted for the remaining device related to this incident.

• Brand Name: ANASTOCLIP GC CLOSURE SYSTEM - VASCULAR & NEURO
• Common Device Name: CLOSURE SYSTEM - VASCULAR & NEURO
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC; 63 second ave; burlington 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington 01803 ; 7814251683
• MDR Report Key: 16919006
• Report Number: 1220948-2023-00081
• Device Sequence Number: 6910766
• Product Code: FZP
• UDI-Device Identifier: 00840663109579
• UDI-Public: (01)00840663109579
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2025
• Device Model Number: 4008-06
• Device Catalogue Number: 4008-06
• Device Lot Number: AGC2352
• 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: 04/12/2023
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• 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
• Patient Sex: Unknown