BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRUITT F3 CAROTID SHUNT

    MDR report key: 11866937 · Received May 21, 2021

    Report

    Report Number
    1220948-2021-00048
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    March 10, 2021
    Report Date
    May 21, 2021
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MJN
    UDI-DI
    00840663101214
    PMA / PMN Number
    K051067
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE COMPLAINT DEVICE FOR INVESTIGATION SINCE IT HAS BEEN DISCARDED BY THE USER. HENCE, WE COULD NOT CONFIRM THE ROOT CAUSE OF THE REPORTED MALFUNCTION. 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. OUR ENGINEERING TEAM HAS ADDRESSED SIMILAR BALLOON DEFLATION ISSUES BY IMPROVING THE DESIGN OF THIS PRODUCT. THE CHANGE INVOLVES THE ADDITION OF INFLATION HOLES UNDER THE BALLOON AND A CHANGE IN THE CUT ANGLE OF THE INFLATION ARM, WHICH WILL ASSIST THE BALLOONS TO INFLATE AND DEFLATE UNIFORMLY ALONG THEIR ENTIRE LENGTH. THE NEW DESIGN HAS BEEN ALREADY APPROVED BY FDA IN NOVEMBER 2018 UNDER K182916. WE HAVE ALREADY STARTED SELLING THE SHUNTS WITH THIS DESIGN IN THE US SINCE EARLY 2019. PLEASE NOTE THAT WE HAVE ALSO REPORTED MANUFACTURER'S REPORT# 1220948-2021-00049 AND 1220948-2021-00050 RELATED TO THE OTHER TWO CASES OF F3 CAROTID SHUNT MALFUNCTION THAT OCCURRED AT THE SAME HOSPITAL.

    Description of Event or Problem · 1

    THE NURSE TESTED THE SHUNT PRIOR TO USE AND IT SEEMED TO WORK. ONCE THE SURGEON PERFORMED THE CAROTID ENDARTERECTOMY, SHE WASN'T ABLE TO DEFLATE THE COMMON BALLOON. SHE HAD TO CUT THE DISTAL PORTION TO HAVE THE CHANCE TO DEFLATE AND REMOVE IT. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THIS INCIDENT. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762485 PRUITT F3 CAROTID SHUNT CAROTID SHUNT MJN LEMAITRE VASCULAR, INC. 2012-10 2012-10 00840663101214

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention