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

Catalog Number 1651-84J

Device Problems Material Rupture (1546); Incomplete or Missing Packaging (2312)

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

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

The product has not been received for investigation.Therefore, we could not conclusively determine the root cause of the reported incidents.Due to the nature of the product, balloon ruptures are an expected risk when using this product.As stated in the ifu: as with all catheterization procedures, complications may occur.These may include but are not limited to: infection, local hematomas, intimal disruption, arterial dissection, perforation and rupture, hemorrhage, arterial thrombosis, distal emboli of blood clots or arteriosclerotic plaque, air embolus, aneurysms, arterial spasms, arteriovenous fistula formation, balloon rupture or tip separation with fragmentation and distal embolization.The possibility of balloon rupture must be taken into account when considering the risks involved in the catherization procedure.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.We have not received any similar complaints related to this lot number.Capa 2021-009 was previously opened to address this issue.No further action needed at this time.

Event Description

It was reported the product did not contain a syringe and a stopcock.Also, the balloon of this catheter was ruptured during the preuse test.The operation was successfully completed using a replacement.No injury was reported 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 17974552
• MDR Text Key: 326135747
• Report Number: 1220948-2023-00181
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100743
• UDI-Public: (01)00840663100743
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1651-84J
• Device Lot Number: XOT1228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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