MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP

Catalog Number	1801-58
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was having a procedure for a left femoral endarterectomy.During the procedure, the probe was removed but with the balloon still inflated.The surgeon sets up the probe and asks to inflate the balloon.In view of the blood return (non-action of the balloon), the surgeon asks to deflate it in order to remove the balloon.Despite several tests, the probe did not deflate and it was impossible to remove it.Balloon was deflated with a scalpel blade and while performing this action, the femoral artery was stripped.As a result of the injury that occurred, an abdominal incision was required to perform a femoral bypass and resulted in a longer intervention for the procedure.
Additional Manufacturer Narrative
The device was not returned for investigation due to the patient having a transmittable disease.Therefore, we're unable to conclusively determine the root cause of the incident.Per the ifu, the following may occur: "in common with other catheterization procedures, complications may occur.These may include intimal disruption, vessel wall perforation, balloon rupture with fragmentation, tip separation, local or systemic infection, arterial thrombosis, local hematomas, air embolus, plaque, arterial dissection, and hemorrhage." we have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP
• Common Device Name: EMBOLECTOMY CATHETER - REGULAR TIP
• 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: 18677178
• Report Number: 1220948-2024-00026
• Device Sequence Number: 6143856
• Product Code: DXE
• UDI-Device Identifier: 00840663100941
• UDI-Public: (01)00840663100941
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K992368
• 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): 02/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1801-58
• Device Lot Number: NSE2454
• 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: 01/12/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown