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

Catalog Number	A4545
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported syntel 5f thrombectomy catheter has a metal spring tip on the end with a silicone cap, this cap can be taken off with fingers during graft/native fistula declotting procedure.When interventionist encounters friction, from the sheath or the vessel wall, this cap becomes loose, and the concern is that it can end in the patient's lungs.The silicone cap was placed back on the metal spring tip.No injury occurred to patient.Note: this is report 2 of 2 related to the second catheter used in the event.Report 1220948-2023-00137 was submitted for the first device involved in this event.
Additional Manufacturer Narrative
The device was received for evaluation.The reported problem was confirmed.The tip of the device was confirmed to be detached.The issue is a result of insufficient glue strength at the tip of the catheter.Due to this issue an awareness memo and retraining was provided to the manufacturing team for this product.The lot history records 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.During manufacturing 8 samples were used for tip pull force testing.All samples passed the pull tests.Note: this is report 2 of 2 related to the second catheter used in the event.Report 1220948-2023-00137 was submitted for the first device involved in this event.

• Brand Name: SYNTEL SILICONE THROMBECTOMY CATHETER
• Common Device Name: THROMBECTOMY 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: 17650614
• Report Number: 1220948-2023-00138
• Device Sequence Number: 6285695
• Product Code: DXE
• UDI-Device Identifier: 00840663109807
• UDI-Public: (01)00840663109807
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 08/30/2023

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 Catalogue Number: A4545
• Device Lot Number: SST1036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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