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

Catalog Number	7210387F
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the reported incident.The status light on the control unit flashed orange when the handpiece was connected into the control unit indicating an issue with the handpiece.The drive shaft did not rotate at all when either the window lock or the run button was pressed.Further inspection found a small amount of moisture in the core tube.It is likely the water ingress inside the core tube damaged the electrical components inside the handpiece affecting the motor functionality.We currently have a corrective and preventive action (capa) open to address this issue.There was no injury to the patient as the result of this incident.Surgeon performed stab phlebectomy to complete the surgery.
Event or Problem Description
During the transilluminated powered phlebectomy procedure (tipp), the handpiece stopped working.

• 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: 8210315
• Report Number: 1220948-2019-00001
• Device Sequence Number: 2878846
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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 Catalogue Number: 7210387F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2018
• Initial Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1