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

Catalog Number	1601-34
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation.Inspection was unable to confirm the reported issue.There was no sign of the catheter lumen being brittle or detaching from the catheter.Some excess glue was observed at the ligature area where the balloon is attached to the catheter, however, this is a clear substance that did not match the photos from the user and there was no sign of the material flaking or detaching from the device.While the provided photos show a foreign substance, it could not be conclusively determined if the material was from the device itself.While the catheter itself did not appear brittle it is possible that the issue occurred during use as a result of the device interacting with other surgical instruments.The production and traceability record for the devices were reviewed; no issues were found during manufacturing or packaging that would cause or contribute to the reported event.We have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported that during a third ventriculoscopy at nch, a green embolectomy catheter was used and was observed to have a defective coating.A portion of the coating reportedly detached and remained in the patient.No additional information regarding the patient's condition was initially provided.Additional information received via email stated that a total of three particles were observed in the patient.According to the operating theatre nurse, the patient experienced no impairment.

• 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: 24700213
• Report Number: 1220948-2026-00055
• Device Sequence Number: 10046693
• Product Code: DXE
• UDI-Device Identifier: 00840663100460
• UDI-Public: (01)00840663100460(11)240905(17)300828(10)SLC00005595(91)1601-34
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: 1601-34
• Device Lot Number: SLC00005595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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