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

Catalog Number	A4E09
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.The exact cause of the reported balloon rupture could not be determined.Balloon ruptures are an inherent risk of using this product.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.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.Note: this is report 1 of 2 related to the first catheter used in the event.Report 1220948-2024-00147 was submitted for the second device involved in this event.
Event or Problem Description
It was reported that the syntel otw balloon ruptured.They were using the python balloon during an ovarian vein embolization procedure and upon inflation they couldn't see any contrast even though they put some in the syringe.Dr.Babcock aspirated the balloon and noticed it had ruptured.This happened with two of the python balloons.No more than 2cc was inflated.They checked the integrity of the second balloon (both devices pre-checked) before placing inside the patient.It was fine until inflated inside the patient, it ruptured again.A different device was used to complete the procedure.No injury was reported to the patient.Note: this is report 1 of 2 related to the first catheter used in the event.Report 1220948-2024-00147 was submitted for the second device involved in this 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: 19918673
• Report Number: 1220948-2024-00135
• Device Sequence Number: 8113663
• Product Code: DXE
• UDI-Device Identifier: 00840663109944
• UDI-Public: (01)00840663109944
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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: A4E09
• Device Lot Number: PYT1205
• 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: 07/09/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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