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

Catalog Number	2012-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During shunt preparation, the surgeon noticed air pressure leakage from the internal carotid balloon (white) to the safety balloon (yellow).Upon inspection, saline leakage was also observed around the safety balloon (yellow).The surgeon confirmed that the recommended inflation volume of 0.25 ml was strictly followed.The device was not used on the patient, and no patient injury was reported.
Additional Manufacturer Narrative
The device was not received for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.It could not be determined whether the issue was related to the manufacturing process or occurred due to handling during pretesting.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).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.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Common Device Name: CAROTID SHUNT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; psong@lemaitre.com; 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: 23530277
• Report Number: 1220948-2025-00198
• Device Sequence Number: 9021282
• Product Code: DXE
• UDI-Device Identifier: 00840663101214
• UDI-Public: (01)00840663101214(11)210203(17)260128(10)QPF1012(91)2012-10
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 11/12/2025

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: 01/28/2026
• Device Catalogue Number: 2012-10
• Device Lot Number: QPF1012
• 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: 02/03/2021
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• 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