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

Model Number	1009-00
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported lemaitre valvulotome had resistance when inserted and ready to deploy during fem-tib bypass procedure resulting in tear of vein.The surgery was prolonged for 5 hours and patient had extended stay in hospital.A second valvulotome was used to resolve the issue.
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.When the green handle was pulled to close the blades into its retainer slot one of the blades was protruding out of the retainer slot and didn't seat properly on the slot.No damage to the blade was found.We observed that the blades were inclined outwards, preventing them from properly inserting into its retainer slot.Capa 2022-025 was previously initiated to address this issue.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.

• Brand Name: LEMAITRE VALVULOTOME
• Common Device Name: VALVULOTOME
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC; 63 second ave; burlington 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington 01803 ; 7814251683
• MDR Report Key: 17309177
• Report Number: 1220948-2023-00111
• Device Sequence Number: 7120619
• Product Code: MGZ
• UDI-Device Identifier: 00840663106653
• UDI-Public: (01)00840663106653
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2026
• Device Model Number: 1009-00
• Device Catalogue Number: 1009-00
• Device Lot Number: ELVH1995V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown