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

Catalog Number E1601-38

Device Problem Material Separation (1562)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

We have received the device for investigation.The reported problem was confirmed, the catheter was observed to be fractured.It was reported, "the balloon seemed to catch and resistance was felt when pressure was applied to remove it.The catheter stretched instead of coming free.The user felt that they did not tug that hard but all of a sudden the catheter came free and was fractured." inspection of the catheter showed signs of excess force being applied during the procedure and the lumen was stretched in multiple places.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.

Event Description

It was reported that the balloon seemed to catch and resistance was felt when pressure was applied to remove it.The catheter stretched instead of coming free.The user felt that they did not tug that hard but all of a sudden the catheter came free and was fractured.The tip broke off and the balloon traveled inside the patient.Multiple services were reviewed and it was deemed the balloon was better off not retrieved and is still inside the patient.Additional information stated the balloon was not ruptured.The device was clamped only after it had already fractured to visualize under x-ray what the end of the catheter looked like (with the clamp as a marker for identification).No intervention was needed.No injury was reported to the patient.

• Brand Name: TUFTEX 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: 18728220
• MDR Text Key: 335963177
• Report Number: 1220948-2024-00052
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/17/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: E1601-38
• Device Lot Number: XSL1280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 02/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• 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
• Patient Outcome(s): Other