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 Patient Involvement (2645)
Date of Event	12/10/2018
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 housing and power cord of the handpiece were visually inspected and were found to be acceptable.The indicator light in the control unit flashed steady green indicating the handpiece was functional.The device was found to be operating properly on all speeds and settings.Upon disassembly of the core tube, we did not observe any moisture inside the core tube.The seal housing appeared to be very clean and was unlikely to have been used in any procedure.Device was not used for the procedure.Procedure was completed using another handpiece that they have in stock.
Event or Problem Description
During pre-use check, the handpiece failed to operate.

• 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: 8232999
• Report Number: 1220948-2019-00004
• Device Sequence Number: 19237772
• Product Code: DWQ
• UDI-Device Identifier: 00840663106561
• UDI-Public: 00840663106561
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2019

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: 7210387F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1