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

Catalog Number 7201387F

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

We have not received the device for evaluation.Hence, we could not conclusively determine the root cause of the defect.The contact person at the hospital stated that the device was picked up by (b)(6).However, the tracking information for this device shows that this unit has not been received by (b)(6).Prior to the procedure, after plugging the handpiece connector into the control unit, the indicator light on the control unit began flashing orange light indicating an issue with the handpiece and the handpiece was found to be non-operational.There has been no serious injury nor the malfunction would 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.The issue was detected during pre-use check.Handpiece was not used in the patient.The procedure was completed using a different handpiece.

Event Description

Handpiece did not operate during pre-use check.

• 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: 8422451
• MDR Text Key: 138970074
• Report Number: 1220948-2019-00026
• Device Sequence Number: 1
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2019

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 Expiration Date: 07/17/2017
• Device Catalogue Number: 7201387F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/14/2019
• 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