MAUDE Adverse Event Report: LeMaitre Vascular, Inc. Pruitt F3 Carotid Shunt

Catalog Number	2012-10
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the white balloon was leaking during a pre-use check.The device was not used on a patient.No patient injury was reported.
Additional Manufacturer Narrative
The photos provided confirmed the reported issue.While the reported event was confirmed, the exact root cause of the reported issue could not be determined.The failure may have resulted from a manufacturing anomaly or from damage incurred 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.

• 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 ; +1(781)425-1683
• MDR Report Key: 50857457
• Report Number: 1220948-2026-00303
• Device Sequence Number: 9553521
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• 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
• Report Date (Section B): 09/22/2026

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: XPF00001290
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2024
• 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