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

Catalog Number 1651-88

Device Problem Material Rupture (1546)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that the tuftex otw failed during pre-use check.The balloon ruptured during pre-test.It was in direct contact with the patient.No injury was reported to the patient.

Manufacturer Narrative

The device was not received for investigation.However, the provided photo confirmed the report.It shows the balloon ruptured.While the reported event was confirmed, the exact root cause of the balloon rupture could not be determined.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.Due to the increased rate of occurrence of this issue a capa has been opened to further investigate the issue.The lot number of the product was not provided.Therefore, we're unable to perform a lot review.

• 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: 19113202
• MDR Text Key: 340904522
• Report Number: 1220948-2024-00087
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100750
• UDI-Public: (01)00840663100750
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/15/2024

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: 1651-88
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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