MAUDE Adverse Event Report: LeMaitre Vascular, Inc. TufTex Over-the-Wire Embolectomy Catheter

Catalog Number	1651-88
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction

• Brand Name: TufTex Over-the-Wire Embolectomy Catheter
• Common Device Name: Over-the-Wire Embolectomy Catheter
• 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 ; +1(781)425-1683
• MDR Report Key: 50935643
• Report Number: 1220948-2026-00314
• Device Sequence Number: 9589347
• Product Code: DXE
• UDI-Device Identifier: 00840663100750
• UDI-Public: (01)00840663100750(11)250919(17)280828(10)XOT00003021(91)1651-88
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152833
• 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): 09/29/2026

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: 1651-88
• Device Lot Number: XOT00003021
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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