MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP; VASICOSE VEIN ABLATION SYSTEM

Catalog Number 7210386F

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

We have not received the complaint device for evaluation.Hence, we could not conclusively determine the root cause of the failure.Surgeon detected the failure with this device during pre-use check.However, the patient was already administered with general anesthetics when the issue was detected.Device was not used for the procedure.Surgeon has to postponed the procedure since they did not have any other control unit in stock to complete the procedure.

Event Description

Trivex control unit did not operate before the procedure.

• Brand Name: TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP
• Type of Device: VASICOSE VEIN ABLATION 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: 9099881
• MDR Text Key: 178784489
• Report Number: 1220948-2018-00131
• 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: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210386F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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