MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC ANASTOCLIP GC CLOSURE SYSTEM; CLIP, IMPLANTABLE

Model Number	4008-06
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Clip will fall out or clip will be partially crimped after activating the applier.Five or six clips will apply perfectly and then a series of 2-3 that fall out uncrimped or do not close completely after squeezing the applier.
Additional Manufacturer Narrative
We have not received the complaint device for evaluation.Hence, we could not conclusively determine the root cause of the incident.Please note that during the in-process inspection, the manufacturing operator visually inspects a sample of the gc clips by checking the tips of the clips are either touching or crossed over to be accepted.A batch review of the affected lot could not be performed since the lot number was not provided to us.We have reviewed our complaint history records for the last 5 years.We have not received any other complaints of a similar nature for anastoclip gc-medium.Hence, we consider this to be an isolated incident.

• Brand Name: ANASTOCLIP GC CLOSURE SYSTEM
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 13830813
• Report Number: 1220948-2022-00019
• Device Sequence Number: 1401271
• Product Code: MJN
• UDI-Device Identifier: 00840663109579
• UDI-Public: 00840663109579
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2022

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 Model Number: 4008-06
• Device Catalogue Number: 4008-06
• Device Lot Number: UNKNOWN
• 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: 02/17/2022
• Initial Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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