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

Model Number	A4E06
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved product was not returned for evaluation.Therefore the root cause of the reported event could not be determined.The device history record was reviewed.No manufacturing or packaging issues were noted that would result in the reported event.Additionally, we have not received any other complaints of a similar nature for other devices from this lot.The ifu provides the following warning: arterial rupture or balloon failure due to sharp calcified plaque may occur.The possibility of balloon rupture must be taken into account when considering the risks involved in the catheterization procedure.There was no injury to the patient as a result of the incident.The surgeon used another device to complete the procedure.
Event or Problem Description
After performing the balloon check before use, the catheter was inserted from the left subclavian artery via the sheath.The catheter was advanced from the left subclavian artery to near the confluence of the aortic arch.The balloon was inflated using the attached syringe, and it was confirmed that the balloon was inflated normally.However, it was confirmed under fluoroscopy that the balloon became smaller before the balloon was deflated.When the catheter was pulled out and confirmed, a rupture of the balloon was confirmed.No patient injury occurred.

• Brand Name: SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 15693837
• Report Number: 1220948-2022-00112
• Device Sequence Number: 12604612
• Product Code: DXE
• UDI-Device Identifier: 00840663109913
• UDI-Public: 00840663109913
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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: 06/28/2025
• Device Model Number: A4E06
• Device Catalogue Number: A4E06
• Device Lot Number: PYT1017
• 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: 09/29/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• 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