MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT F3 CAROTID SHUNT

Catalog Number	2013-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation; therefore, the root cause of the reported incident could not be conclusively determined.It could not be established whether the issue occurred during the manufacturing or packaging process, or if the product was damaged during handling or preparation prior to use.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 met their requirements.We have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported that the shunt was leaking at the coupling, and as a result, it could not be held in place and slipped out.The surgeon noted that the shunt slipped out after a short period of time, and it was concluded that decreased balloon pressure caused the displacement.The device was checked prior to use.The patient is doing well, and a new shunt was used to complete the procedure without issue.The product was discarded and is not available for investigation.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Common Device Name: CAROTID SHUNT
• 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: 23573195
• Report Number: 1220948-2025-00207
• Device Sequence Number: 9885609
• Product Code: DXE
• UDI-Device Identifier: 00840663101252
• UDI-Public: (01)00840663101252(11)220223(17)270128(10)QPF1150(91)2013-10
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K182916
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: 2013-10
• Device Lot Number: QPF1150
• 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: 10/22/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2022
• 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
• Patient Sex: Unknown