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

Catalog Number	A4E08
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured during inflation to remove a blood clot for an embolectomy procedure.The saline volume did not exceed the recommended volume.It appears the catheter was used at the stenotic regions.No fragment was left inside the patient.The device was checked prior to use.The procedure was successfully completed using another device.No injury was reported to the patient.
Additional Manufacturer Narrative
The product was not returned for investigation.The exact cause of the reported balloon rupture could not be determined.Balloon ruptures are an inherent risk of using this product.As stated in the ifu, complications may occur during the use of embolectomy catheters.These may include intimal disruption, vessel wall perforation, balloon rupture with fragmentation, tip separation, local or systemic infection, arterial thrombosis, local hematomas, air embolus, rupture of an aneurysm, arterial spasm, distal embolus of blood clots or arteriosclerotic plaque, arterial dissection, and hemorrhage.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 catherization procedure.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.

• 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 20587607
• Report Number: 1220948-2024-00213
• Device Sequence Number: 20474839
• Product Code: DXE
• UDI-Device Identifier: 00840663109937
• UDI-Public: (01)00840663109937(11)230712(17)280628(10)PYT1182(91)A4E08
• 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): 11/01/2024

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: A4E08
• Device Lot Number: PYT1182
• 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: 10/02/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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