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

Model Number	1009-00
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the surgeon, a patient with critical limb ischemia was indicated for femoropopliteal venous in situ bypass and disobliteration.Before using the valvulotome a standard preparation was performed - rinsing and repeated test of the functionality of the valvulotome by the operator.The saph.Magna vein was of borderline width, but usable for in situ bypass.The valvulotome was introduced from the distal end of the vein graft proximally in the closed position to the proximal end of the graft.Before sewing the proximal anastomosis, the surgeon needed to slightly pull back the valvulotome, it was still in a closed position.However, when moving backward, the catheter was immediately blocked.During the open revision of the blocked catheter, the surgeon found that there was a longitudinal laceration of the vein graft with a length of 10 cm.The cause was the eccentric protrusion of 1 valvulotome knife, which caused laceration of the graft.The valvulotome was still in the closed position.The damage of the vein graft was so extensive that it could not be used for the bypass.A different graft was used to complete the operation.
Additional Manufacturer Narrative
We have received the complaint device for evaluation, and the reported incident was confirmed.Additionally, the device was returned with the distal portion, including the blades cut off of the device.As a result, the blades were not able to be actuated using the green handle.On distal portion that contained the blades, one of the blades was observed protruding out of the retainer slot and didn't seat properly on the slot.The blade was misaligned preventing it from properly inserting into its retainer slot.The root cause of this issue 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.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, 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: 15340769
• Report Number: 1220948-2022-00090
• Device Sequence Number: 17857982
• Product Code: MGZ
• UDI-Device Identifier: 00840663106653
• UDI-Public: 00840663106653
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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 Model Number: 1009-00
• Device Catalogue Number: 1009-00
• Device Lot Number: ELVH1969V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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
• Patient Sex: Unknown