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

Catalog Number	7201387F
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.The status light on the control unit initially flashed solid green when the handpiece was connected into the control unit.The status light on the control unit flashed orange when the run button was pressed indicating an issue with the handpiece and the drive shaft was observed to rotate hesitantly.The status light on the control unit also flashed green when the lock button was pressed and the drive shaft rotated hesitantly.The issue was detected during pre-use check.Handpiece was not used in the patient.The procedure was completed using a different handpiece.
Event or Problem Description
Handpiece did operate 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: 8379085
• Report Number: 1220948-2019-00016
• Device Sequence Number: 13834161
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/27/2019

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: 7201387F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1