MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. EZE-SIT VALVULOTOME

Model Number	TIVK2030
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Tried to flush the valvulotome the connection was broken.Frequent problem.New product obtained.Fda safety report id# (b)(4).

• Brand Name: EZE-SIT VALVULOTOME
• Common Device Name: VALVULOTOME
• Manufacturer (Section D): LEMAITRE VASCULAR, INC. ; burlington MA 01803
• MDR Report Key: 11946481
• Report Number: MW5101727
• Device Sequence Number: 14375798
• Product Code: MGZ
• UDI-Device Identifier: 00840663102297
• UDI-Public: 00840663102297
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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 Expiration Date: 08/28/2026
• Device Model Number: TIVK2030
• Device Lot Number: TRU1073
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 100