MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP

Catalog Number	E1801-58
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for investigation.The reported problem was confirmed.The failure occurred due to the ligature failing and the inflated balloon slipping past the skive hole which prevented the balloon from inflating.The ligature likely failed due to the pull force on the catheter during the procedure.It is possible that procedural factors including stenosis or calcified plaque caused additional pull force to be used during thrombus removal and contributed to the failure.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.We have not received any similar complaints related to this lot number.
Event or Problem Description
It was reported that the balloon could not be deflated during an embolectomy procedure.The operation was successfully completed using an alternative device.It is not known if the device was pre-checked prior to use.No injury was reported to the patient.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP
• Common Device Name: EMBOLECTOMY CATHETER - REGULAR TIP
• 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: 22846624
• Report Number: 1220948-2025-00141
• Device Sequence Number: 18243552
• Product Code: DXE
• UDI-Device Identifier: 00840663101009
• UDI-Public: (01)00840663101009(11)240318(17)290228(10)NSE00003032(91)E1801-28
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: E1801-58
• Device Lot Number: NSE00003032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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