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

Catalog Number	2013-10
Medical Device Problem Codes	Inflation Problem (1310); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not available for return.As a result, the root cause of the reported issue could not be conclusively determined.During use it is possible if the balloons are inflated too rapidly or over inflated that the safety balloon activates.If the safety balloon becomes over inflated or if inflated too often it may stretch and provide less resistance over time resulting in the internal carotid balloon being unable to inflate.The safety balloon is intended to inflate when excess pressure is applied to the internal carotid balloon to reduce the possibility of injury by over-inflation.As instructed in the ifu, the balloon should be slowly inflated to prevent the safety balloon from inflating and the user should slide the safety sleeve over the safety balloon once the balloon is in place.When balloon inflation is completed, the ifu instructs to: close the white stopcock and slide the movable sleeve over the external safety balloon.This will prevent reflux from the internal carotid balloon into the external safety balloon and prevent subsequent loss of vessel occlusion.The lot number of the product was not provided.Therefore, the device history record could not be reviewed.
Event or Problem Description
It was reported that the pruitt f3 shunt internal balloon was dislodging and the safety balloon also inflated prior to internal balloon during a carotid endarterectomy procedure.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: 20481766
• Report Number: 1220948-2024-00210
• Device Sequence Number: 8275843
• Product Code: MJN
• UDI-Device Identifier: 00840663101252
• UDI-Public: (01)00840663101252
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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: 2013-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/18/2024
• 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
• Patient Sex: Unknown