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

Catalog Number	A4E09
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for investigation.However, it was stated the balloon ruptured due to over inflation.Therefore, the cause of the reported issue is due to user error.Per the ifu: "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).Maximum recommended inflation volumes should not be exceeded (see specification table).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 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 1 of 2 related to the first catheter used in the event.
Event or Problem Description
It was reported that the syntel otw catheter balloon ruptured during a brto procedure.The surgeon over inflated the balloon.A replacement device was used to complete the operation.The device was checked prior to use.The surgeon saw the balloon ruptured through imaging.No report of injury to the patient.Note: this is report 1 of 2 related to the first 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: 22437706
• Report Number: 1220948-2025-00105
• Device Sequence Number: 3238042
• Product Code: DXE
• UDI-Device Identifier: 00840663109944
• UDI-Public: (01)00840663109944(11)201104(17)251028(10)PYT1037(91)A4E09
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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 Expiration Date: 10/28/2025
• Device Catalogue Number: A4E09
• Device Lot Number: PYT1037
• 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: 06/10/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2020
• 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