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	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the reported incident.Initially, we observed the control unit to operate on all settings and functions.However, upon further testing, we noticed a hesitation in the operation of the resector and observed that the harness connector was loose.The connector was most likely damaged by the operator while moving the resector power cable negligently or during insertion/removal of the resector power cable into the control unit.A loose connector can cause intermittent connection and can cause the handpiece to operate intermittently.There was no injury to the patient.The issue was detected during pre-use check and the procedure was completed using a different control unit.
Event or Problem Description
During pre-use check, the handpiece failed to operate when it was connected to 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 02148
• MDR Report Key: 7957433
• Report Number: 1220948-2018-00079
• Device Sequence Number: 201330
• Product Code: DWQ
• UDI-Device Identifier: 00840663106530
• UDI-Public: 00840663106530
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2011

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: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1