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

Catalog Number	E2012-11
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the device for investigation.Therefore, we could not conclusively determine the root cause of the reported incident.While the exact cause of the internal carotid balloon failing to inflate remains unknown, it is possible that the safety balloon inflated due to overinflation of the internal carotid balloon.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.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.Further, we have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported that the white internal carotid balloon would not inflate during the procedure.A stent was placed to resolve the issue.The bleeding was able to be controlled, and no harm occurred 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: 20127683
• Report Number: 1220948-2024-00161
• Device Sequence Number: 16940865
• Product Code: MJN
• UDI-Device Identifier: 00840663101290
• UDI-Public: (01)00840663101290
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: E2012-11
• Device Lot Number: XPF1026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown