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

Catalog Number 7210387F

Device Problem No Device Output (1435)

Patient Problem No Information (3190)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation.When the handpiece was connected into a control unit, the indicator light on the control unit flashed orange indicating an issue with the handpiece.We were unable to rotate the drive shaft when either the run or the window lock button was pressed.Upon disassembly, we did not noted any component failure and the adhesive on the pc board appeared to be in properly working condition.The seal housing was observed to have heat discoloration.The likely root cause of this issue is a seized ball bearing.Over time, particulates and water could enter into the ball bearing assembly since it is not a hermetically sealed component.We have already implemented a corrective and preventive action (capa) to resolve this issue by replacing the ball bearings with slip bearings which better prevent the bearings from corrosion and from seizing.This device was manufactured prior to the implementation of these changes.There was no harm to the patient as the result of this incident.The procedure was completed using a different handpiece.

Event Description

The resector failed to rotate during pre-use check.

• 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: 8593242
• MDR Text Key: 145792610
• Report Number: 1220948-2019-00054
• 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: 05/08/2019

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: YQ01541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/08/2019
• 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