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	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The reported issue was confirmed.The distal ligature slipped causing the balloon to move down over the spring tip allowing fluid to leak instead of inflating the balloon.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.
Event or Problem Description
It was reported at the time of performing a maneuver in the procedure, the guide tip tends to detach in the area where the balloon is located.There were no patient injury reported.

• 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: 16902474
• Report Number: 1220948-2023-00084
• Device Sequence Number: 5371531
• 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): 05/11/2023

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
• Device Model Number: A4545
• Device Catalogue Number: A4545
• Device Lot Number: SST1032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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