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

Catalog Number	7210387F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.The housing and powercord were visually inspected and found to be acceptable.The handpiece was ran for several minutes.However, we could not replicate the reported defect.However, during our evaluation, the drive shaft was rotating intermittently even after releasing the run or the window lock button.Upon disassembly, we observed water inside the core tube.The seal housing also had visual signs of heat discoloration which suggests that the device was overheated at some point.The root cause was determined to be a seal failure that led to water ingress into the handpiece, which adversely 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.Device was not used for the procedure.Procedure was completed using another handpiece that they had in stock.
Event or Problem Description
During pre-use check, the handpiece was overheating.Device was not used for the tipp procedure.

• 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: 8505541
• Report Number: 1220948-2019-00041
• Device Sequence Number: 1062606
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/11/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1