MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE VALVULOTOME

Model Number	1009-00
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lemaitre valvulotome blades could no longer be closed.No injury was reported.The user mentioned that they had a similar incident occur in january as well.Please note that report 1220948-2023-00070 was also submitted for the report of a similar incident.
Additional Manufacturer Narrative
The device was not received for evaluation.Therefore, the reported issue could not be confirmed and the root cause could not be determined.Due to similar reports, a corrective and preventive action (capa) was previously opened to further investigate this issue.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.Please note that report 1220948-2023-00070 was also submitted for the related incident.

• Brand Name: LEMAITRE VALVULOTOME
• Common Device Name: VALVULOTOME
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 16779324
• Report Number: 1220948-2023-00069
• Device Sequence Number: 6709374
• Product Code: MGZ
• UDI-Device Identifier: 00840663106653
• UDI-Public: (01)00840663106653
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2023

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 Model Number: 1009-00
• Device Catalogue Number: 1009-00
• Device Lot Number: ELVH2152V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown