MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER

Catalog Number	1651-34
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received for investigation.However, the photo provided confirmed the reported issue.It could not be determined if the issue occurred due to an issue during the manufacturing or packaging process, or if the product was damaged during handling or preparation prior to use.Additionally, it is possible that procedural factors/anatomical features such as calcification, or plaque caused/contributed to the reported issue.The dhr was not available to review.
Event or Problem Description
It was reported that during an av shunt thrombectomy, the physician reported feeling as though the tip of the catheter tore while it was being withdrawn.Resistance was encountered during the procedure; however, it was necessary to continue pulling the catheter.As a result, the catheter tip was retrieved in a partially torn condition.No patient injury was reported.
Additional Manufacturer Narrative
The device was not received for investigation.However, the photo provided confirmed the reported issue.It could not be determined if the issue occurred due to an issue during the manufacturing or packaging process, or if the product was damaged during handling or preparation prior to use.Additionally, it is possible that procedural factors/anatomical features such as calcification, or plaque caused/contributed to the reported issue.The production and traceability record for the device was reviewed; no issues were found during manufacturing or packaging that would cause or contribute to the reported event.All quality control tests were completed successfully and met specification.We have not received any other complaints of a similar nature for devices from this lot.

• 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 ; 9784251683
• MDR Report Key: 24109573
• Report Number: 1220948-2026-00007
• Device Sequence Number: 5816572
• Product Code: DXE
• UDI-Device Identifier: 00840663100651
• UDI-Public: (01)00840663100651(11)250729(17)310628(10)OTW00005008(91)1651-34
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: 1651-34
• Device Lot Number: OTW00005008
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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