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

Model Number	1009-00
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received from the canada vigilance program regarding an incident where a lemaitre valvulotome device had the lines to the blades remained exposed while the device was pulled closed, the surgeon felt resistance and caused trauma to the intima.
Additional Manufacturer Narrative
We have not received the complaint device for evaluation, therefore we are unable to confirm the reported event.Previous investigation into the reported blade issue has determined the root cause to be a centering hoop to wire welding error along with operator adjustment error.The blade assembly process includes manual manipulation of each blade by the operator.Operator errors are possible due to the manual nature of the adjustments.Our review of the lot history records for this lot found an ncmr related to this failure mode, however during manufacturing 100% testing and inspection is performed on these components to detect blade issues prior to releasing the product.The product related to the ncmr for this lot were not released.Additionally, we have not received any other complaints of a similar nature for devices from this lot.A corrective and preventive action (capa) has been opened to address this issue.

• 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: 15505425
• Report Number: 1220948-2022-00107
• Device Sequence Number: 5285644
• Product Code: MGZ
• UDI-Device Identifier: 00840663106653
• UDI-Public: 00840663106653
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 1009-00
• Device Catalogue Number: 1009-00
• Device Lot Number: ELVH1049V
• 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: 09/01/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2015
• 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: Other
• Patient Sex: Unknown