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

Model Number 2012-10

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  malfunction  

Event Description

It was reported that the pruitt f3 carotid shunt leaked on insertion.The shunt was changed to a new shunt for the procedure.No injury occurred.Upon further inspection the site found a hole at the connection of the blue inflation line and the main shunt body.

Manufacturer Narrative

The product was not available for return, as a result the exact root cause could not be determined.A photo of the device confirmed the report of leakage at the joint between the inflation lumen and the main shunt lumen.The leak occurred due to the inflation lumen becoming partially dislodged from the main shunt body.It could not be determined if this was due to a manufacturing error or due to improper handling of the device prior to use.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.We have not received any similar complaints related to this lot number.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Type of Device: CAROTID SHUNT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC; 63 second ave; burlington 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington 01803 ; 7814251683
• MDR Report Key: 17298382
• MDR Text Key: 318880695
• Report Number: 1220948-2023-00112
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: (01)00840663101214
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K182916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2023

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
• Device Operator: Health Professional
• Device Model Number: 2012-10
• Device Catalogue Number: 2012-10
• Device Lot Number: QPF1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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