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

Catalog Number	4008-06
Medical Device Problem Codes	Failure to Form Staple (2579); Mechanical Jam (2983)
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a bvt procedure, the anastoclip gc clip applier jammed and stuck onto the patient's arm and could not get it to release the clip or off the patient's arm.They had to cut out part of the vein.Device was checked prior to use.A replacement device was used to complete the operation.No other issues or injury were reported to the patient.
Additional Manufacturer Narrative
The device was received for investigation.During testing the device, the clips were able to close completely and deployed properly from the device.No issue occurred during testing.The cause of the issue during the procedure could not be determined.It is possible that an intermittent issue caused the clip to become stuck during the procedure.Due to similar reported issues, capa 2025-004 has been initiated to further investigate and address the issue.No further action is required.The lot history record for the devices was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.We have not received any other complaints of a similar nature for devices from this lot.

• 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: 22729546
• Report Number: 1220948-2025-00130
• Device Sequence Number: 15525823
• Product Code: FZP
• UDI-Device Identifier: 00840663109579
• UDI-Public: (01)00840663109579(11)250130(17)291228(10)AGC00002562(91)4008-06
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K091987
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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 Catalogue Number: 4008-06
• Device Lot Number: AGC00002562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown