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	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for investigation.The reported problem was confirmed.The balloon was observed to be ruptured.While the reported event was confirmed, the exact root cause of the reported issue could not be determined.The ifu provides the following warning related to the complications possible when using these devices: in common with other catheterization procedures, complications may occur.These may include intimal disruption, vessel wall perforation, balloon rupture with fragmentation, tip separation, local or systemic infection, arterial thrombosis, local hematomas, air embolus, rupture of aneurysm, arterial spasm, distal embolus of blood clots or arteriosclerotic plaque, arterial dissection, and hemorrhage.Exercise caution when encountering extremely diseased vessels.Arterial rupture or balloon failure due to sharp calcified plaque may occur.Excessive handling during insertion, or plaques and other deposits within the vessel may damage the balloon and can increase the possibility of balloon rupture.The possibility of balloon rupture must be taken into account when considering the risks involved in the catheterization procedure.Due to the increased rate of occurrence of this issue capa 2024-007 has been opened to further investigate the issue.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Note: this is report 1 of 2 related to the first catheter used in the event.
Event or Problem Description
It was reported that the tuftex otw balloon ruptured during a procedure.No injury was reported to the patient.Note: this is report 1 of 2 related to the first catheter used in the event.
Additional Manufacturer Narrative
The device was not received for investigation.Therefore, the exact root cause of the reported issue could not be determined.The ifu provides the following warning related to the complications possible when using these devices: in common with other catheterization procedures, complications may occur.These may include intimal disruption, vessel wall perforation, balloon rupture with fragmentation, tip separation, local or systemic infection, arterial thrombosis, local hematomas, air embolus, rupture of aneurysm, arterial spasm, distal embolus of blood clots or arteriosclerotic plaque, arterial dissection, and hemorrhage.Exercise caution when encountering extremely diseased vessels.Arterial rupture or balloon failure due to sharp calcified plaque may occur.Excessive handling during insertion, or plaques and other deposits within the vessel may damage the balloon and can increase the possibility of balloon rupture.The possibility of balloon rupture must be taken into account when considering the risks involved in the catheterization procedure.Due to the increased rate of occurrence of this issue capa 2024-007 has been opened to further investigate the issue.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Note: this is report 1 of 2 related to the first catheter used in the event.

• 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 ; 7814251683
• MDR Report Key: 21512333
• Report Number: 1220948-2025-00038
• Device Sequence Number: 15458956
• Product Code: DXE
• UDI-Device Identifier: 00840663100743
• UDI-Public: (01)00840663100743(11)240404(17)300328(10)XOT00001717(91)1651-84
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: 1651-84
• Device Lot Number: XOT00001717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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