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

Catalog Number	E2013-10
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for investigation.The reported problem was observed.The safety balloon was damaged and leaking.While the reported event was confirmed, the exact root cause of the reported issue could not be determined.It is possible to damage the safety balloon if the user mishandled the device when removing the safety sleeve or if the sleeve was incorrectly moved in the direction of the stopcock instead of toward the infusion area of the internal carotid lumen.As stated in the ifu: the sheath should be moved and hang loosely on the infusion area of the distal lumen (away from the stopcock area).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.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 pruitt f3 carotid shunt white balloon was not inflating during a carotid endarterectomy procedure.It was not used on the patient.A replacement device was used to complete the operation.No injury was reported to the patient.

• 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: 21950356
• Report Number: 1220948-2025-00078
• Device Sequence Number: 8553992
• Product Code: DXE
• UDI-Device Identifier: 00840663101320
• UDI-Public: (01)00840663101320(11)210505(17)260428(10)QPF1038(91)E2013-10
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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 Expiration Date: 04/28/2026
• Device Catalogue Number: E2013-10
• Device Lot Number: QPF1038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• 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