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

Catalog Number	7210387F
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The resector failed to rotate during pre-use check.

• Brand Name: TRIVEX SYSTEM RESECTOR HANDPIECE
• Common Device Name: VARICOSE VEIN ALBATION SYSTEM
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• MDR Report Key: 8593242
• Report Number: 1220948-2019-00054
• Device Sequence Number: 2169957
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K032387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1