MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP

Catalog Number 1801-26

Device Problems Inflation Problem (1310); Material Rupture (1546)

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

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

We have not received the device for evaluation.Therefore, we could not conclusively determine the root cause of the incident.The lot number of the product was not provided.Therefore, we're unable to perform a lot review.Balloon rupture is a known complication with this type of product and is not an indication of a systemic issue with the product.As stated in the ifu: in common with other catheterization procedures, complications may occur.These may include intimal disruption, vessel wall perforation, balloon rupture with fragmentation, tip separation, local or systemic infection, arterial thrombosis, local hematomas, air embolus, plaque, arterial dissection, and hemorrhage.Exposure to calcified plaques may increase the risk of balloon rupture.

Event Description

It was reported that the syntel silicone embolectomy catheter - regular tip balloon ruptured in a very calcified vessel.Doctor stated it was due to the patient and not a product defect.It was an incident to be expected in the given situation.No injury was reported to the patient.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP
• Type of Device: EMBOLECTOMY CATHETER - REGULAR TIP
• 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: 18960477
• MDR Text Key: 339291421
• Report Number: 1220948-2024-00068
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100880
• UDI-Public: 00840663100880
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K992368
• 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: 03/22/2024

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: 1801-26
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/22/2024
• 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