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

Catalog Number	2011-10
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two pruitt carotid shunts experienced issues during internal carotid balloon inflation.In the first case, the internal carotid balloon ruptured on the first inflation attempt.In the second case, the balloon did not inflate uniformly and appeared weak, leading the physician to discontinue use of the device.A third shunt was subsequently used and functioned as intended.No patient injury was reported.One device was discarded, and it is unclear whether the second device will be returned.Note: this report is 1 of 2 related to the first shunt used in the event.
Additional Manufacturer Narrative
The device was discarded and not available for investigation; therefore, the root cause of the reported incident could not be conclusively determined.Balloon rupture is an inherent risk associated with the use of this product.Due to the nature of the device and the procedures for which it is used, procedural factors or anatomical features, such as calcification or plaque, may have caused or contributed to the reported issue.If additional device or event details are received, separate reports will be submitted for each event.As stated in the ifu: "exercise caution when encountering extremely diseased vessels.Arterial rupture or balloon failure due to sharp calcified plaque may occur.Avoid extended or excessive exposure to fluorescent light, heat, sunlight, or chemical fumes to reduce balloon degradation." 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.We have not received any other complaints of a similar nature for devices from this lot.Note: this report is 1 of 2 related to the first shunt used in the 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: 24649806
• Report Number: 1220948-2026-00046
• Device Sequence Number: 9842211
• Product Code: MJN
• UDI-Device Identifier: 00840663101191
• UDI-Public: (01)00840663101191(11)221003(17)270928(10)XPF1017(91)2011-10
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: 2011-10
• Device Lot Number: XPF1017
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2022
• 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