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	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tuftex otw balloon ruptured during the procedure.The device was pre-checked prior to use.No patient injury was reported.
Additional Manufacturer Narrative
The provided photo confirmed the reported balloon rupture; however, there was no evidence of blood on the device to indicate that it had been used on the patient.While the balloon rupture was confirmed, the exact root cause of the reported issue could not be determined.Balloon rupture is an inherent risk associated with the use of this product.Balloon rupture is an inherent risk of using this product.As stated in the ifu: avoid extended or excessive exposure to fluorescent light, heat, sunlight, or chemical fumes to reduce balloon degradation.Do not exceed the recommended maximum balloon liquid capacity (see specifications).Due to the increased rate of occurrence of this issue, capa 2026-007 was created to document and investigate the failure.The production and traceability record for the device was reviewed; no issues were found during manufacturing or packaging that would cause or contribute to the reported event.All quality control tests were completed successfully and met specification.

• 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: 50428555
• Report Number: 1220948-2026-00262
• Device Sequence Number: 10377864
• Product Code: DXE
• UDI-Device Identifier: 00840663100750
• UDI-Public: (01)00840663100750(11)250919(17)280828(10)XOT00003019(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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: XOT00003019
• 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: 07/30/2026
• Initial Report FDA Received Date: 08/25/2026
• 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