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

Model Number	4008-07
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the user, the clips of the anastoclip did not close properly.
Additional Manufacturer Narrative
We have received the complaint device for evaluation.We observed the clips were properly positioned on the tip of the jaw.When we attempted to release the clips from the applier, we observed the clips did not close completely and failed the gap specification.We noted that there was not enough stack pressure when we pushed the clips downwards.However, when we removed the back cover of the anastoclip and attempted to eject the clips, the clips closed and released properly.Based on our device evaluation, it is likely that the device was not assembled properly during our manufacturing process.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.The malfunction was detected during the pre-use check.The surgeon used another anastoclip to clip the vessel.

• Brand Name: ANASTOCLIP GC CLOSURE SYSTEM
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; lemaitre vascular, inc.; 63 second ave 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: 15124974
• Report Number: 1220948-2022-00068
• Device Sequence Number: 12595043
• Product Code: MJN
• UDI-Device Identifier: 00840663109586
• UDI-Public: 00840663109586
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2022

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 Expiration Date: 08/28/2026
• Device Model Number: 4008-07
• Device Catalogue Number: 4008-07
• Device Lot Number: AGC2378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown