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

Catalog Number	A4E08
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received for investigation.However, the photos provided confirmed the report.Due to the nature of the device and the procedures it is being used for, the reported issue is a known complication of using the device.It is possible that procedural factors/anatomical features such as calcification, or plaque caused/contributed to the reported issue.As stated in the ifu, complications may occur during the use of embolectomy catheters.These may include intimal disruption, vessel wall perforation, balloon rupture with fragmentation, tip separation, local or systemic infection, arterial thrombosis, local hematomas, air embolus, rupture of an aneurysm, arterial spasm, distal embolus of blood clots or arteriosclerotic plaque, arterial dissection, and hemorrhage.Arterial rupture or balloon failure due to sharp calcified plaque may occur.The possibility of balloon rupture must be taken into account when considering the risks involved in the craterization procedure.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.Note: this is report 3 of 3 related to the third catheter used in the event.
Event or Problem Description
It was reported that after opening the packaging, the physician conducted a pre-use inspection before applying the device to the patient.This included balloon inflation and the injection of saline into the guidewire lumen.No issues were identified at that time, so he proceeded with the thrombectomy.After passing through the stenotic area and inflating the balloon to the specified volume, he attempted to withdraw the catheter.However, he noticed an unusual lack of resistance.When he tested balloon inflation outside the body, he found that the balloon had ruptured.No injury was reported to the patient.Note: this is report 3 of 3 related to the third catheter used in the event.

• Brand Name: SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: 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: 22606395
• Report Number: 1220948-2025-00115
• Device Sequence Number: 5385217
• Product Code: DXE
• UDI-Device Identifier: 00840663109937
• UDI-Public: (01)00840663109937(11)240919(17)290828(10)PYT00001325(91)A4E08
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: A4E08
• Device Lot Number: PYT00001325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown