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	Failure to Conduct (1114)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the reported incident from the picture of the defect provided to us by the hospital.The control unit connector had come loose, pressed into the control unit and could not make a connection with the pins of the handpiece cable.The operator could have pushed the handpiece cable too hard to connect into the connector of the control unit.As a result, some nuts inside the port could have loosened up and resulted in this issue.There was no injury to the patient as the result of this incident.However, they had to postponed the procedure to a later date since they did not have any other control unit in stock at that time to complete the procedure.
Event or Problem Description
During transilluminated powered phlebectomy surgery (tipp), the handpiece failed to operate since it could not make a proper connection with the control unit.As a result, surgeon had to postpone the procedure to a later time since they did not have any other control unit in stock at that time to complete the procedure.

• 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 02148
• MDR Report Key: 8181195
• Report Number: 1220948-2018-00110
• Device Sequence Number: 2112475
• Product Code: DWQ
• UDI-Device Identifier: 00840663106530
• UDI-Public: 00840663106530
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/19/2018

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: 12/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1