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	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and not available for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.Balloon rupture is an inherent risk associated with this type of device, and given the nature of the product and the procedures in which it is used, this event is considered a known complication.Procedural factors or anatomical features, such as calcification or plaque, may have contributed to the reported issue.As stated in the instructions for use (ifu), complications may occur during the use of embolectomy catheters.These may include, but are not limited to: 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 also occur.The possibility of balloon rupture must be taken into account when evaluating the risks of catheterization procedures.A lot history review was conducted, and no issues were identified in the manufacturing or packaging processes that could be related to this event.All quality control testing met specifications.
Event or Problem Description
It was reported that prior to patient use, a pre-use inspection was performed.The physician inflated the balloon and injected normal saline into the guidewire lumen, determining the product to be acceptable before proceeding with the thrombectomy.The catheter tip successfully passed through the stenotic lesion, and the balloon was inflated with the specified amount of normal saline.However, during withdrawal of the catheter, the physician noticed an unexpected lack of resistance.Subsequent external inspection, performed by attempting to inflate the balloon outside the body, confirmed that the balloon had ruptured.The procedure was successfully completed using a spare unit of the same product available at the clinic, with no further issues.No harm to the patient's health was reported.

• 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: 23701074
• Report Number: 1220948-2025-00212
• Device Sequence Number: 16109351
• Product Code: DXE
• UDI-Device Identifier: 00840663109937
• UDI-Public: (01)00840663109937(11)250414(17)300328(10)PYT00001386(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): 12/02/2025

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: PYT00001386
• 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: 11/07/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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