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

Catalog Number	7210386F
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.However, we were unable to replicate the reported defect during our evaluation.The control unit was found to be functioning properly at all settings and speeds.The control unit was tested multiple times but we did not observe any failure with the control unit.During the procedure at the hospital, the indicator light on the control unit properly flashed orange indicating an issue with the handpiece.The surgeon then exchanged the handpiece and then increased the rpm on this control unit which resolved this issue.We have subsequently evaluated three handpieces that were returned from this hospital that may have been used in this case.Our evaluation found two of the three handpieces were operating intermittently.It is possible that a faulty handpiece led to this incident rather than the control unit which was evaluated to be fully functional.There was no injury to the patient as the result of this incident.
Event or Problem Description
During transilluminated powered phlebectomy (tipp), the control unit stopped working periodically flashing orange light on the control unit.

• Brand Name: TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP
• Common Device Name: VARICOSE VEIN ALBATION SYSTEM
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 8318309
• Report Number: 1220948-2019-00010
• Device Sequence Number: 1954636
• Product Code: DWQ
• UDI-Device Identifier: 00840663106530
• UDI-Public: 00840663106530
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/07/2019

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: 7210386F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1