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

Catalog Number A4E04

Device Problems Material Rupture (1546); Material Perforation (2205)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

The device was discarded and not returned for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.However, it was stated the patient was pre-operated and treated endovascular with stents and in areas of calcification.The lot number of the product was not provided.Therefore, we're unable to perform a lot review.Due to limited information initially being made available, additional information was gathered from the surgeon.Communication with the surgeon has determined that no serious harm occurred to the patient and the blood loss was not critical or a result of using the product.Additionally, they stated that the issue occurred due to the surgery being performed in non-standard areas of the human anatomy or in areas with stents and/or calcification that are difficult to navigate and manipulate the catheters in.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.Do not exceed the maximum recommended volume, as over inflation increases the possibility of balloon rupture.Exercise caution when encountering extremely diseased vessels.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.Based on all this info, the reported issue is considered to be an expected and foreseeable side effect and an event caused by patient conditions.The issue was likely due to the patient's condition (calcified vessel), use of the product near a stent, and therefore the failure is a known inherent risk of the product.

Event Description

According to a survey, it was reported the balloon ruptured during a procedure.Additionally, they reported blood loss of 2000ml; however, it was not critical and not directly from use of the device.Also, higher perforation compared to a normal fogarty catheter.The balloon rupture did not prolong the procedure.The doctor does not believe it was a product issue.Their main issue is that they operate often not in a normal human area or anatomy.Often the patients are pre-operated and treated endovascular with stents and in areas of calcification.Often, it's hard to navigate in these manipulated areas.So, it was not a big concern that the balloon ruptured.They are considering tuftex otw in the future, as the balloon has more strength.No other complications or injury were reported to the patient.

• Brand Name: SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Type of Device: 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: 18986739
• MDR Text Key: 338709452
• Report Number: 1220948-2024-00073
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663109890
• UDI-Public: (01)00840663109890
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K202049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A4E04
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other