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

Model Number 2012-10

Device Problem Inflation Problem (1310)

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

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.We observed a leakage at the blue stopcock joint when we attempted to inject liquid into the common carotid balloon.As a result, the common carotid balloon failed to inflate.Upon further inspection of the joint, we observed an inadequate amount of glue at the stopcock joint.The internal carotid balloon inflated and deflated properly.The root cause of the malfunction was determined to be a manufacturing operator error- not enough glue was applied on the stopcock joint during the assembly process.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.We have implemented a corrective and preventive action (capa) to address this issue and prevent them from reoccurring.The corrective action includes retaining and qualifying operators for the gluing operations.The malfunction was detected during the pre-use check.This device was not used for the procedure.

Event Description

The surgeon observed a leakage from the shunt when he attempted to inflate one of the balloons with saline.

• 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: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 13060056
• MDR Text Key: 287198779
• Report Number: 1220948-2021-00119
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: 00840663101214
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051067
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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: QPF1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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