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

Catalog Number 7210387

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

We have not received the device for evaluation since the device is still at the hospital.Hence, we could not conclusively determine the root cause of the defect.On (b)(6) 2019, our sales rep.Reported that the handpiece did not work during pre-use check.The surgeon then used another handpiece that they have in stock to complete the phlebectomy procedure.There has been no serious injury nor would the malfunction result in a death or serious injury if it was to reoccur since the handpiece could not be used for the procedure.However, we have decided to report the incident since our evaluation was based on the reported defect from our sales rep.And the user at the hospital rather than our hands-on evaluation with this defective device itself.

Event Description

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

• 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: 8558236
• MDR Text Key: 145943340
• Report Number: 1220948-2019-00049
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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