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

Catalog Number	2012-10
Medical Device Problem Codes	Material Rupture (1546); Thickening of Material (4056)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received for evaluation.Therefore, we could not conclusively determine the root cause of the reported incident.Balloon rupture is an inherent risk of using this product.As stated in the ifu: avoid extended or excessive exposure to fluorescent light, heat, sunlight, or chemical fumes to reduce balloon degradation.Do not exceed the recommended maximum balloon liquid capacity (see specifications).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 7 of 8 related to the seventh shunt used in the event.
Event or Problem Description
It was reported that balloon thickened and ruptured during use on a patient.However, additional information received states that the balloon rupture did not occur on a patient and was during pre-testing.Over the past 2 months there have cases of the balloon rupturing during the pre-use check.We attempted to clarify the report, but it was not successful.No injury was reported to the patient.Note: this is report 7 of 8 related to the seventh 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: 22662273
• Report Number: 1220948-2025-00124
• Device Sequence Number: 3702294
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: (01)00840663101214(11)230925(17)280828(10)XPF1142(91)2012-10
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 07/30/2025

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: XPF1142
• 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: 06/30/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2023
• 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