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	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation.The reported problem was not duplicated.The blades were able to be opened and closed properly with no resistance or issues.The cause of the injury is likely a result of the procedure being performed.The ifu warning states: "do not insert the lemaitre valvulotome into a vessel or extract from a vessel in the open position.Do not rotate the lemaitre valvulotome in a vessel.Do not advance the lemaitre valvulotome with the blades in the open position.Failure to sheath the cutting blades and centering hoops prior to retracting the device from the vein may cause damage." and the potential complication while using the device is "vessel wall perforation".This lot passed the quality control testing during manufacturing and met acceptance criteria for release.Additionally, we have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported lemaitre valvulotome did not resheath at final step of withdrawal during leg revascularization procedure.Upon withdraw 2cm of vein was injured requiring that section to be excised followed by a splice graft.The final withdraw was partially exposed.Patient had prolonged stay at hospital.

• 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: 17316643
• Report Number: 1220948-2023-00114
• Device Sequence Number: 19842734
• Product Code: MGZ
• UDI-Device Identifier: 00840663106653
• UDI-Public: (01)00840663106653
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/13/2023

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 Model Number: 1009-00
• Device Catalogue Number: 1009-00
• Device Lot Number: ELVH2257V
• 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: 06/13/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown