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

Catalog Number E2012-10

Device Problem Inflation Problem (1310)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Therefore, we're unable to conclusively determine the root cause of the reported incident.It is unknown if the devices were checked prior to use.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.It is possible the balloon was over inflated or inflated too rapidly and resulted in the safety balloon inflating instead of the internal carotid balloon.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 1 of 2 related to the first shunt used in the event.Report 1220948-2024-00019 was submitted for the second device involved in this event.

Event Description

It was reported that two pruitt f3 carotid shunts had a defect in the tubing that caused inflation in wrong part of tubing leading to underinflation of the fixated balloon which caused dislocation of the shunt and bleeding during a left carotid endarectomy procedure.They are unsure if the devices were checked prior to use.No other injury was reported to the patient.Note: this is report 1 of 2 related to the first shunt used in the event.Report 1220948-2024-00019 was submitted for the second device involved in this event.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Type of Device: 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: 18521408
• MDR Text Key: 332953760
• Report Number: 1220948-2024-00018
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00840663101283
• UDI-Public: (01)00840663101283
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E2012-10
• Device Lot Number: XPF0076
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention