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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.The outer housing and power cord were visually inspected and were found to be acceptable.The handpiece was plugged into the control unit.The motor did not run smoothly when the run or the window lock button was pressed in the forward direction.Upon disassembly, water was observed inside the core tube.At this time, we could not conclusively determine the root cause of the failure that led to water ingress into the handpiece which adversely affected the motor functionality.Device was not used for the procedure.Procedure was completed using another handpiece that they had in stock.
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: 8597024
• Report Number: 1220948-2019-00056
• Device Sequence Number: 2074734
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7210387F
• Device Lot Number: YB02265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1