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

Catalog Number 4000-07

Device Problem Mechanical Jam (2983)

Patient Problem Failure to Anastomose (1028)

Event Date 02/24/2019

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.The gap distance between clips did not consistently pass our specification of 0.006".The gap between the clip cover and the applier jaw was within our acceptable limit and there was adequate stack force being applied on the clips.At this time, we are inconclusive about the root cause of the defect but the investigation is on-going.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.We have not received any other complaints of a similar nature for devices from this lot from other customers.There was no injury to the patient.The procedure was completed by using another anastoclip vcs device ( lot# unknown ).Please note that we have also submitted manufacturer's report number: 1220948-2019-00031 for another case that was reported to us by the same surgeon.

Event Description

One large anastoclip vcs appliers failed to close the vascular tissue properly during anastomosis.This is report 2 of 2.

• Brand Name: ANASTOCLIP VCS CLOSURE SYSTEM
• Type of Device: CLIP, IMPLANTABLE AND DELIVERY 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: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 8458458
• MDR Text Key: 140306042
• Report Number: 1220948-2019-00032
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00840663102372
• UDI-Public: 00840663102372
• Combination Product (y/n): N
• PMA/PMN Number: K091987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: 4000-07
• Device Lot Number: ANC2194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2018
• 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