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

Model Number 4008-06

Device Problems Loose or Intermittent Connection (1371); Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 315085776
• Report Number: 1220948-2023-00081
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00840663109579
• UDI-Public: (01)00840663109579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1