MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TUFTEX EMBOLECTOMY CATHETER

Catalog Number	1601-28
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and therefore not available for direct investigation.Balloon rupture is an inherent risk associated with the use of this product.It is possible that procedural factors/anatomical features such as calcification, or plaque caused/contributed to the reported issue.As stated in the instructions for use (ifu): "as with all catheterization procedures, complications may occur.These may include, but are not limited to infection, local hematomas, intimal disruption, arterial dissection, perforation and rupture, hemorrhage, arterial thrombosis, distal emboli of blood clots or arteriosclerotic plaque, air embolus, aneurysms, arterial spasms, arteriovenous fistula formation, balloon rupture, or tip separation with fragmentation and distal embolization.The history record for the device was reviewed.No issues were identified during manufacturing or packaging that would have caused or contributed to the reported event.Additionally, no other complaints of a similar nature have been received for devices from this lot.
Event or Problem Description
It was reported that the tuftex slc balloon ruptured in a patient's vessel during a procedure.No patient injury was reported.

• Brand Name: TUFTEX 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 ; 7814251683
• MDR Report Key: 23654269
• Report Number: 1220948-2025-00210
• Device Sequence Number: 4903218
• Product Code: DXE
• UDI-Device Identifier: 00840663100453
• UDI-Public: (01)00840663100453(11)231005(17)290928(10)XSL1625(91)1601-28
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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: 1601-28
• Device Lot Number: XSL1625
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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