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

Catalog Number	1601-58
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.Balloon ruptures are an inherent risk of using this product.According to the ifu "the tuftex embolectomy catheter is indicated for the removal of arterial emboli and thrombi." the device is not indicated for the use of removing gallstones or cholecystectomy.It is possible that anatomical features involved in this procedure caused/contributed to the reported issue.Additionally, as stated in the 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 lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.
Event or Problem Description
It was reported that during a cholecystectomy procedure, when the catheter was introduced through the bile duct for stone extraction, it failed to inflate.Upon removal, the balloon was found to be ruptured.It is important to note that prior to use, the catheter had been inflated with saline solution without any issues.No injury was reported to the patient.

• 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: 23024605
• Report Number: 1220948-2025-00160
• Device Sequence Number: 9181820
• Product Code: DXE
• UDI-Device Identifier: 00840663100514
• UDI-Public: (01)00840663100514(11)220512(17)280428(10)SLC5559(91)1601-58
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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
• Device Catalogue Number: 1601-58
• Device Lot Number: SLC5559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2022
• 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