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

Catalog Number	1009-00
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for investigation as it was discarded at the site; therefore, the root cause of the reported incident could not be conclusively determined.Previous investigations into this issue have found the failure was likely due to a centering hoop to wire welding error along with operator adjustment error.During the welding process, this centering hoop was likely not properly aligned against its retainer slot.Capa 2022-025 was previously implemented to address this issue.The device involved was manufactured after the capa was implemented.Although the issue occurred post-implementation, the overall occurrence of this issue has decreased since the capa was put in place.The production and traceability record for the device was reviewed; no issues were found during manufacturing or packaging that would cause or contribute to the reported event.All quality control tests were completed successfully and met specification.We have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported that upon opening the package, the sheath did not fully retract, leaving the blade exposed.The device was not used on a patient.No patient injury was reported.

• 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 24468687
• Report Number: 1220948-2026-00034
• Device Sequence Number: 15984109
• Product Code: MGZ
• UDI-Device Identifier: 00840663106653
• UDI-Public: (01)00840663106653(11)250902(17)300828(10)ELVH00002883(91)1009-00
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/27/2026

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: 1009-00
• Device Lot Number: ELVH00002883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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