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

Catalog Number	2012-10
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received for evaluation.Therefore, the exact root cause of the reported issue could not be determined.It is possible that anatomical factors such as calcification or stenosis contributed to the failure.Balloon rupture is an inherent risk of using this product.Due to the nature of the device and the procedures it is being used for, the reported issue is a known complication of using the device.It is possible that procedural factors/anatomical features such as calcification, or plaque caused/contributed to the reported issue.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 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.Note: this is report 1 of 2 related to the first shunt used in the event.
Event or Problem Description
On (b)(6) 2025, during carotid surgery, the shunt experienced spontaneous rupture of the proximal balloon.The device was used according to standard procedure and was inflated in line with the manufacturer's instructions for use (ifu).No external force or misuse was reported during handling.There was no patient injury reported.The patient underwent successful treatment and was discharged from the hospital on (b)(6) 2025.Note: this is report 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.; 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 ; 7814251683
• MDR Report Key: 22952962
• Report Number: 1220948-2025-00147
• Device Sequence Number: 20897970
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: (01)00840663101214(11)240404(17)290328(10)XPF00001206(91)2012-10
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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 Catalogue Number: 2012-10
• Device Lot Number: XPF00001206
• 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: 08/05/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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