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

Model Number 2012-10

Device Problem Leak/Splash (1354)

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

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

The provided video confirmed the report.It shows leakage from both the blue balloon and safety balloon.The product was not returned; therefore, a root cause could not be conclusively determined.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.Note: this is report 1 of 4 related to the first catheter used in the event.Reports 1220948-2023-00108, 1220948-2023-00109, 1220948-2023-00110 were submitted for the second, third, and fourth devices involved in this event.

Event Description

It was reported 4 pruitt f3 carotid shunt leaked during water test.There were no patient involvement.Note: this is report 1 of 4 related to the first catheter used in the event.Reports 1220948-2023-00108, 1220948-2023-00109, 1220948-2023-00110 were submitted for the second, third, and fourth devices involved in this event.

• Brand Name: PRUITT F3
• 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: 17305272
• MDR Text Key: 319450123
• Report Number: 1220948-2023-00107
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: (01)00840663101214
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K182916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• 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: XPF1010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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