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

Catalog Number	E2012-10
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation and the reported issue was confirmed.The device was observed to be 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 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.All qc tests passed their requirements.
Event or Problem Description
It was reported that the pruitt f3 shunt leaked at the distal inflation port during pre-use check.It was not used directly on the patient.A replacement shunt was used to complete the operation.No injury was reported to the patient.

• 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: 22572865
• Report Number: 1220948-2025-00112
• Device Sequence Number: 18531670
• Product Code: MJN
• UDI-Device Identifier: 00840663101283
• UDI-Public: (01)00840663101283(11)240710(17)290628(10)XPF00001244(91)E2012-10
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: E2012-10
• Device Lot Number: XPF00001244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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