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

Catalog Number	2012-10
Medical Device Problem Codes	Degraded (1153); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a carotid endarterectomy, the yellow balloon on the shunt did not inflate properly, and the safety balloon inflated before the main balloon.It is unknown whether the devices were inspected or tested prior to use.The patient possibly has a carotid artery stenosis.No patient injury was reported at the time of the event.Note: this is report 2 of 2 related to the second shunt used in the event.
Additional Manufacturer Narrative
The device was discarded and unavailable for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.As stated in the ifu: avoid extended or excessive exposure to fluorescent light, heat, sunlight, or chemical fumes to reduce balloon degradation.Do not exceed the recommended maximum balloon liquid capacity (see specifications).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.Note: this is report 2 of 2 related to the second shunt used in the event.

• 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 ; +1(781)425-1683
• MDR Report Key: 50684039
• Report Number: 1220948-2026-00281
• Device Sequence Number: 12053633
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: (01)00840663101214(11)221108(17)271028(10)XPF1044(91)2012-10
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: XPF1044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2022
• 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