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

Model Number	A4E01
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and have confirmed the reported incident.The device was inspected and the balloon was confirmed to be ruptured.The product was in use at the time of the failure.Inspection of the device could not determine a precise root cause for the failure.It was reported that the blood vessel had slight calcification, therefore it is possible that the balloon came in contact with a calcification during the procedure.According to the ifu, balloon failure due to sharp calcified plaque may occur.There was no patient injury resulting from the event.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.Please note that we have also submitted manufacturer incident report number 1220948-2022-00083 relating to one other syntel silicone over-the-wire embolectomy catheter malfunction that occurred during this event.
Event or Problem Description
The syntel silicone over-the-wire embolectomy catheter was used in a thrombectomy of a dialysis patient.After preparing the product, the artificial blood vessel was incised and the catheter tip was inserted into the vein.When the balloon was inflated and the thrombus removal in the artificial blood vessel (with slight calcification) was started, the balloon was ruptured easily.A second product from the same lot was prepared and used for this operation.When the thrombus was attempted to remove from the artificial blood vessel and the venous anastomosis (with mild stenosis), the balloon was ruptured.The physician prepared the third catheter and completed the procedure without any problems.The patient is fine.No health damage happened.This is report 1 of 2.

• Brand Name: SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• 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: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 15287002
• Report Number: 1220948-2022-00082
• Device Sequence Number: 14023059
• Product Code: DXE
• UDI-Device Identifier: 00840663109869
• UDI-Public: 00840663109869
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202049
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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 Model Number: A4E01
• Device Catalogue Number: A4E01
• Device Lot Number: PYT1066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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