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

Model Number	A4E01
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user has discarded the device since it was used on a patient with an infectious disease.Hence, we could not conclusively determine the root cause of the incident.The surgeon used the catheter to remove the clot in a dialysis patient.According to the surgeon, there was no stenosis or calcification around the region where the catheter was operated.After the first pass, he observed the saline that was inside the balloon started leaking from the distal end of the balloon.The surgeon did not experience resistance when removing the clot.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.There was no harm to the user because of the balloon malfunction.The surgeon used another catheter to complete the procedure.
Event or Problem Description
The balloon of the syntel over-the-wire embolectomy catheter ruptured during an embolectomy procedure.So, the surgeon used another catheter for the procedure.There was no harm to the patient because of this incident.

• Brand Name: SYNTEL OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; lemaitre vascular, inc.; 63 second ave MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 15703495
• Report Number: 1220948-2022-00028
• Device Sequence Number: 6227396
• Product Code: DXE
• UDI-Device Identifier: 00840663109869
• UDI-Public: 00840663109869
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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: 12/28/2025
• Device Model Number: A4E01
• Device Catalogue Number: A4E01
• Device Lot Number: PYT1055
• 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: 03/14/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2021
• 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