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

Catalog Number	4008-06
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We did not receive the device for investigation since it was discarded by the user.Hence, we could not conclusively determine the root cause of the reported malfunction.Per the ifu: "squeeze the levers together fully until a discernible click is felt.Failure to squeeze the levers completely can result in clip malformation and possible bleeding or leakage.Check tightness of clip placement.Tissue should completely fill clip opening and clip should not loosely rock side to side." 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.We have not received any similar complaints related to this lot number.
Event or Problem Description
It was reported that the anastoclip gc clips were not closing and gripping properly when used during the case.It had to be removed them from the dura during a tethered cord procedure.No injury was reported to the patient.

• Brand Name: ANASTOCLIP GC CLOSURE SYSTEM - VASCULAR & NEURO
• Common Device Name: CLOSURE SYSTEM
• 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 20021675
• Report Number: 1220948-2024-00156
• Device Sequence Number: 7336427
• Product Code: FZP
• UDI-Device Identifier: 00840663109579
• UDI-Public: (01)00840663109579
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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 Catalogue Number: 4008-06
• Device Lot Number: AGC00002522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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