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

Catalog Number 7210387F

Device Problem Failure to Conduct (1114)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation.However, we were unable to replicate the reported defect during our evaluation.The housing and power cord of the handpiece were visually inspected and were found to be acceptable.The indicator light in the control unit flashed steady green indicating the handpiece was functional.The device was found to be operating properly on all speeds and settings.Upon disassembly of the core tube, we did not observe any moisture inside the core tube.The seal housing appeared to be very clean and was unlikely to have been used in any procedure.Device was not used for the procedure.Procedure was completed using another handpiece that they have in stock.

Event Description

During pre-use check, the handpiece failed to operate.

• 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: 8232999
• MDR Text Key: 134329776
• Report Number: 1220948-2019-00004
• Device Sequence Number: 1
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 7210387F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2017
• 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