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	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The lemaitre valvulotome could no longer be closed.It was reported metal threads are visible on the head.The blades became unable to close.No injury reported to the patient.The patient is doing fine.
Additional Manufacturer Narrative
We have received the complaint device for evaluation and 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 sit properly on the slot.No damage to the blade was found.We observed that the blade was inclined outwards, preventing it from properly inserting into its retainer slot.Previous investigations into this issue have found the failure was determined to be 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.The blade process includes manual manipulation of each blade by the operator.Operator errors are possible due to the manual nature of the adjustments.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.Capa 2022-025 was opened to further investigate this issue.

• 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: 16898949
• Report Number: 1220948-2023-00085
• Device Sequence Number: 6837358
• 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): 05/09/2023

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: ELVH2087V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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