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 Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.The handpiece cable and power cable were inspected and were found to be acceptable.Handpiece was then connected into the control unit.When either the run or the window lock button was pressed, the indicator light on the control unit flashed orange indicating an issue with the handpiece and the drive shaft would not turn.Upon disassembly, we did not observe any component failure.However, 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 hermatically 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: 8597023
• MDR Text Key: 145138486
• Report Number: 1220948-2019-00055
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210387F
• Device Lot Number: YB02177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Date Manufacturer Received: 04/10/2019
• 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