MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER

Catalog Number	1651-84
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tuftex otw balloon ruptured during preoperative inspection prior to patient use and was therefore not utilized in the procedure.A replacement device was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
The device was not received for investigation; however, the provided photo and video confirmed the reported issue.The video shows leakage from the bottom ligature of the balloon.It is possible that the balloon was overinflated, resulting in rupture prior to use.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 2024-007 was previously implemented to document further investigation of this 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: 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 ; 9784251683
• MDR Report Key: 24589537
• Report Number: 1220948-2026-00041
• Device Sequence Number: 13132823
• Product Code: DXE
• UDI-Device Identifier: 00840663100743
• UDI-Public: (01)00840663100743(11)240812(17)300728(10)XOT00002359(91)1651-84
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: 01803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: 1651-84
• Device Lot Number: XOT00002359
• 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: 02/12/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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