MAUDE Adverse Event Report: LeMaitre Vascular, Inc. Syntel Silicone Over-the-Wire Embolectomy Catheter

Catalog Number	A4E04
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction

• 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 ; +1(781)425-1683
• MDR Report Key: 50936038
• Report Number: 1220948-2026-00315
• Device Sequence Number: 16139713
• Product Code: DXE
• UDI-Device Identifier: 00840663109890
• UDI-Public: (01)00840663109890(11)250226(17)300128(10)PYT00001371(91)A4E04
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 09/29/2026

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: A4E04
• Device Lot Number: PYT00001371
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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