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

Catalog Number 7201386F

Device Problem Failure to Conduct (1114)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2018

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 12/07/2018, our sales rep.Reported to us that the connector on this control unit was pushed into its housing.So, the surgeon could not connect the handpiece cable into the connector.He then used another control unit that they have in stock to complete the phlebectomy procedure.There has been no serious injury (section 2.13) 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.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

The connector in the control unit was pushed into the housing.The issue was detected before the procedure.

• 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: 8219839
• MDR Text Key: 133362964
• Report Number: 1220948-2019-00003
• Device Sequence Number: 1
• Product Code: DWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7201386F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention