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

Catalog Number	7201387F
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Handpiece did not operate during pre-use check.

• Brand Name: TRIVEX SYSTEM RESECTOR HANDPIECE
• Common Device Name: VARICOSE VEIN ALBATION SYSTEM
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• MDR Report Key: 8422451
• Report Number: 1220948-2019-00026
• Device Sequence Number: 1795118
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K032387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2017
• Device Catalogue Number: 7201387F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1