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	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and not available for evaluation.However, the photos provided confirmed the report.The balloon of the device was observed to be ruptured.While the reported event was confirmed, the exact root cause of the reported issue could not be determined.No further investigation can be performed without return of the complaint device.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: do not inflate the internal carotid balloon to any greater volume than is necessary to obstruct blood flow for the internal carotid artery.Do not exceed the recommended maximum balloon liquid capacity.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.Deflate the balloons prior to shunt removal.Avoid using excessive force to push or pull the shunt against resistance.The device history record (dhr) for the device was reviewed.The review found no issues during manufacturing or packaging that would cause or contribute to the reported event.The lot passed all qc testing and the lot was found to meet specification required for sale.
Event or Problem Description
It was reported that the pruitt f3 carotid shunt balloon ruptured in the middle of a carotid endarterectomy (cea) procedure.The doctors almost finished suturing the patch on the carotid artery when the incident happened.They proceeded with clamps and quickly finished the remaining sutures.After the shunt was removed, dr.(b)(6) did further inspection on the balloon; no parts or small pieces of the balloon came off the balloon.Device was pre-checked prior to use.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: 22739226
• Report Number: 1220948-2025-00136
• Device Sequence Number: 7188981
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: (01)00840663101214(11)220608(17)270528(10)XPF0061(91)2012-10
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

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: XPF0061
• 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: 07/09/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2022
• 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