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

Catalog Number 1651-48

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

Event Description

It was reported that during use the fill port of the catheter detached from the injection base.In addition the distal tip had leakage around the balloon with a risk of part of the device detaching in the patient.The issue occurred with two devices.No injury was reported to the patient.Another catheter from the same batch presented the same problem.Note: this is report 2 of 2 related to the second catheter used in the event.Report 1220948-2023-00146 was submitted for the first device involved in this event.

Manufacturer Narrative

The device have not been returned for evaluation.Therefore, we're unable to conclusively determine the root cause of the reported incident.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.We have not received any similar complaints related to this lot number.Note: this is report 2 of 2 related to the second catheter used in the event.Report 1220948-2023-00146 was submitted for the first device involved in this event.

• Brand Name: TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER
• Type of Device: 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: 17736683
• MDR Text Key: 323918101
• Report Number: 1220948-2023-00147
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100682
• UDI-Public: (01)00840663100682
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K022145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2023

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 Operator: Health Professional
• Device Catalogue Number: 1651-48
• Device Lot Number: OTW4501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1