MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TRIVEX SYSTEM RESECTOR HANDPIECE; VARICOSE VEIN ALBATION SYSTEM

Catalog Number 7210387F

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation.However, we were unable to confirm the reported incident as we were unable to replicate the reported incident during our evaluation.The housing and power cord were visually inspected and were found acceptable.The indicator on the control unit properly flashed solid green when the handpiece was connected to the control unit.The device properly functioned on all settings and speed.Upon disassembly, water was observed inside the core tube.The root cause was determined to be a seal failure that led to water ingress into the handpiece, which intermittently affected the motor functionality.We currently have a capa open to address this issue.The corrective action includes repairs by replacing the current seal housing with a new seal housing assembly, o-rings and switch pcb and motor if there is any evidence of water inside the core tube.We believe these changes will better prevent water and steam from entering into the inner components of the handpiece.Procedure was completed using another handpiece that they had in stock.

Event Description

During tipp ( transilluminated powered phlebectomy) procedure, the resector failed to rotate.So, the procedure was completely using a different handpiece.There was no injury or any adverse event to the patient as the result of this incident.

• Brand Name: TRIVEX SYSTEM RESECTOR HANDPIECE
• Type of Device: VARICOSE VEIN ALBATION SYSTEM
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• 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: 8532737
• MDR Text Key: 142783666
• Report Number: 1220948-2019-00044
• Device Sequence Number: 1
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7210387F
• Device Lot Number: YB02407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1