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

Catalog Number 7201386

Device Problem Failure to Conduct (1114)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2019

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.There has been no serious injury nor would the malfunction result in a death or serious injury if it was to reoccur since the control unit could not be used for the procedure and the issue was detected during pre-use check.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 device itself.

Event Description

During pre-use check, the control unit shut off automatically multiple times.

• Brand Name: TRIVEX SYSTEM CONTROL UNIT
• 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: 8609587
• MDR Text Key: 145541748
• Report Number: 1220948-2019-00057
• Device Sequence Number: 1
• Product Code: DWQ
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7201386
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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