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

Catalog Number	E1601-48
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was undergoing lower extremity vascular surgery (thrombectomy) due to concern for arterial occlusion.During a portion of the procedure, after evacuating thrombus, the catheter passed proximally in the femoral artery when it became lodged and could not be removed after multiple attempts.Femoral arteriotomy was performed to locate the catheter which was in the profunda femoris artery.Profunda was dissected, but the tip of catheter could not be released with attempts to pass embolectomy catheters proximally to it or with instrumentation used to dislodge it.The catheter was pulled from the artery, and the balloon section was noted to have been separated from the catheter shaft.It could not be palpated in the profunda.Length of the catheter was compared by markings with another 4fr embolectomy catheter on the field to determine that approximately 1.5-2cm balloon tip segment remained in the patient.The part of the vessel where the catheter became stuck contained an area of calcified plaque.The catheter tip is believed to be retained in a small arterial branch off the profunda vessel and is not believed to present risk of harm to the patient going forward.No other issue or injury to the patient was reported.
Additional Manufacturer Narrative
The device has not been received for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.The damage is likely due to excessive pull force during the procedure.It was stated that the area where the balloon became stuck was in an area of calcified plaque.Therefore, it is likely that the failure occurred due to additional pull force being used while attempting to remove the catheter from the calcified plaque.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.Further, we have not received any other complaints of a similar nature for devices from this lot.

• 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: 22977551
• Report Number: 1220948-2025-00152
• Device Sequence Number: 15747422
• Product Code: DXE
• UDI-Device Identifier: 00840663100606
• UDI-Public: (01)00840663100606(11)230504(17)290428(10)XSL1428(91)E1601-48
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: E1601-48
• Device Lot Number: XSL1428
• 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: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2023
• 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