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

Catalog Number	2012-10
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported approximately four (4) years ago that the customer experienced an incident in which, during removal of a shunt, the device reportedly sliced/cut the patient's artery.The event was not reported at the time of occurrence, and the device was subsequently discarded and is therefore unavailable for investigation.The physician repaired the affected artery, and no further consequences or injury to the patient were reported.
Additional Manufacturer Narrative
The device was discarded and unavailable for investigation.Therefore, the reported incident could not be confirmed, and the root cause could not be conclusively determined.Based on the limited information available, it could not be determined whether the reported event was attributable to a device defect or to the procedural technique used during the operation.No further details regarding the reported incident were available.The lot number was not provided; therefore, a lot-specific review could not be performed.

• 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: 50859112
• Report Number: 1220948-2026-00304
• Device Sequence Number: 9498354
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2012-10
• Device Lot Number: Unknown
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown