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	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The provided photo confirmed the report.The balloon was observed to be ruptured.While the reported event was confirmed, the exact root cause of the reported issue could not be determined.As stated in the ifu: "handle with care.Product should be stored in a clean, cool, dry area away from chemical fumes.Do not inflate the balloon to any greater volume than is necessary to obstruct the blood flow.Do not exceed the recommended maximum balloon inflation capacity (see specifications).Caution: do not exceed the maximum recommended volume, as over inflation increases the possibility of balloon rupture.Refer to specifications for maximum inflation capacities." the production and traceability record for the device was reviewed; no issues were found during manufacturing or packaging that would cause or contribute to the reported event.All quality control tests were completed successfully and met specification.We have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported that the syntel otw balloon ruptured during pre-testing prior to use in a procedure.The device was not used on the patient, and an alternative device was utilized to complete the operation.No patient injury 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: 24714910
• Report Number: 1220948-2026-00059
• Device Sequence Number: 5726509
• Product Code: DXE
• UDI-Device Identifier: 00840663109890
• UDI-Public: (01)00840663109890(11)250226(17)300128(10)PYT00001370(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): 03/27/2026

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: PYT00001370
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/30/2026
• 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