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	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pruitt f3 carotid shunt leaked at the stopcock joint during pre-testing prior to insertion into the patient.The device was not used.No patient injury was reported.
Additional Manufacturer Narrative
The device was discarded and not available for investigation; however, the video provided confirmed leaking at the stopcock joint.Previous investigation into the issue has found the root cause of the malfunction to be a manufacturing operator error, not enough glue was applied on the stopcock joint during the assembly process.Due to reports of similar issues, the product design is being reviewed through dhf0155 to address this issue.The production and traceability record for the device was reviewed; no issues were found during manufacturing or packaging that would cause or contribute to the reported event.All quality control tests were completed successfully and met specification.
Additional Manufacturer Narrative
The device was discarded and was not available for investigation.However, review of the video provided shows leakage originating from the balloon and not from the stopcock.While the reported issue was confirmed, the exact root cause could not be determined due to the unavailability of the device for evaluation.The failure may have been the result of a manufacturing anomaly or potential damage during packaging, shipping, or handling prior to use.The production and traceability record for the device was reviewed; no issues were found during manufacturing or packaging that would cause or contribute to the reported event.All quality control tests were completed successfully and met specification.
Event or Problem Description
Note: a correction is being submitted after video review, which confirmed that the leakage originated from the balloon rather than the stopcock.

• 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: 24045532
• Report Number: 1220948-2026-00005
• Device Sequence Number: 10498681
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: (01)00840663101214(11)240710(17)290628(10)XFP00001241(91)2012-10
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K811276
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 2012-10
• Device Lot Number: XPF00001241
• 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: 12/16/2026
• Supplement Date Received by Manufacturer: 12/16/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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