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	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and not available for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.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.
Event or Problem Description
It was reported that the balloon ruptured during pre-use testing.The procedure was completed using a replacement product.No patient injury was reported.

• 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: 25026764
• Report Number: 1220948-2026-00105
• Device Sequence Number: 10126423
• Product Code: DXE
• UDI-Device Identifier: 00840663100750
• UDI-Public: (01)00840663100750(11)250729(17)280628(10)XOT00002866(91)1651-88
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K022145
• 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): 04/29/2026

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: XOT00002866
• 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: 04/03/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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