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

Catalog Number 1651-38

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.The catheter was observed to be broken in multiple places and was returned in multiple pieces.When the catheter was handled during the inspection the material was unable to bend and broke with little force applied to the material.Although the reported error was confirmed, inspection of the product was unable to determine if the cause was related to a manufacturing issue or if the product was exposed to conditions that could have compromised the material prior to use.The root cause of the issue could not be determined.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot, therefore we believe this is an isolated incident.

Event Description

While using a tuftex over-the-wire embolectomy catheter for percutaneous embolectomy of the superficial femoral artery through a large-lumen sluice, the catheter broke in half into many small pieces that had to be removed from the vessel.According to the surgeon, there was still the same number of pieces in the vessel at that time.All have been removed.If you touch the catheter, more pieces break off immediately.There was no injury to the patient.

• 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: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 15287209
• MDR Text Key: 305586736
• Report Number: 1220948-2022-00081
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/24/2022

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: 1651-38
• Device Lot Number: OTW4167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2019
• 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): Required Intervention