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

Catalog Number	2012-12
Medical Device Problem Codes	Degraded (1153); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.It is likely the device was damaged during the manufacturing process or during handling prior to use.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.
Event or Problem Description
It was reported that the pruitt f3 shunt has a punctured proximal balloon.Found during pre-use test.No injury reported to patient.
Additional Manufacturer Narrative
The device was received for evaluation.The common carotid (blue) balloon was found degraded/cracked.While the reported damaged balloon was confirmed, the exact cause could not be determined.It is possible that the product was exposed to abnormal storage conditions, excess heat/light exposure or was damaged while preparing the device for the procedure.The ifu states: "since natural rubber latex is affected by environmental conditions, proper storage procedures must be practiced to achieve optimum shelf life.The product should be stored in a cool dark area away from fluorescent lights, sunlight, and chemical fumes to prevent premature deterioration of the rubber balloon.Proper stock rotation should be practiced." 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.

• 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: 20941227
• Report Number: 1220948-2024-00249
• Device Sequence Number: 18176507
• Product Code: MJN
• UDI-Device Identifier: 00840663101238
• UDI-Public: (01)00840663101238(11)221003(17)270928(10)XPF1012(91)2012-12
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 02/05/2025

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: 2012-12
• Device Lot Number: XPF1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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