MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SYNTEL SILICONE THROMBECTOMY CATHETER

Model Number	A4545
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported three tip of the catheters were damaged during extraction of the thrombus.Part of the tip tends to detach.There were no patient injury reported.
Additional Manufacturer Narrative
We have not received the product for investigation.The provided photos confirmed the report.The balloon appears to be damaged and the distal ligature detached.However, we could not conclusively determine the root cause of the reported incident.The lot history record for the device was reviewed.Five were rejected during the rubber tip application process; however, visual inspection is performed for all devices and the remaining devices for this lot passed inspection.Please note that this is report 2 of 3.Reports 1220948-2023-00074 and 1220948-2023-00076 were submitted for the remaining 2 devices related to this incident.

• Brand Name: SYNTEL SILICONE THROMBECTOMY CATHETER
• Common Device Name: THROMBECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC; 63 second ave; burlington 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington 01803 ; 7814251683
• MDR Report Key: 16862198
• Report Number: 1220948-2023-00075
• Device Sequence Number: 5958007
• Product Code: DXE
• UDI-Device Identifier: 00840663109807
• UDI-Public: (01)00840663109807
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K910372
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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 Model Number: A4545
• Device Catalogue Number: A4545
• Device Lot Number: SST1032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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