BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRUITT F3 CAROTID SHUNT

    MDR report key: 11866936 · Received May 21, 2021

    Report

    Report Number
    1220948-2021-00050
    Event Type
    Malfunction
    Date Received
    May 21, 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 THEY HAVE BEEN DISCARDED BY THE USER. HENCE, WE COULD NOT CONFIRM THE ROOT CAUSE OF THE REPORTED MALFUNCTION. WE COULD NOT PERFORM A BATCH RECORD REVIEW OF THE AFFECTED LOT SINCE THE LOT NUMBER WAS NOT PROVIDED TO US. 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# 1220948-2021-00048 AND 1220948-2021-00049 RELATED TO THE OTHER TWO CASES OF F3 CAROTID SHUNT MALFUNCTION THAT OCCURRED AT THE SAME HOSPITAL.

    Description of Event or Problem · 1

    WHEN THE SURGEON NOTIFIED THE SALES REP. ABOUT THE INCIDENT (MANUFACTURER'S REPORT# 1220948-2021-00048) RELATED TO A F3 CAROTID SHUNT MALFUNCTION, SHE ALSO INFORMED HER ABOUT A SIMILAR INCIDENT THAT OCCURRED THE PREVIOUS MONTH. IN THIS CASE, AFTER THE SURGEON COMPLETED THE CAROTID ENDARTERECTOMY PROCEDURE, SHE WAS UNABLE TO DEFLATE THE BALLOON OF THE INTERNAL CAROTID BALLOON. SO, HE HAD TO FORCE IT SLIGHTLY OUT BEFORE BEING ABLE TO PUNCTURE THE BALLOON AND REMOVE THE SHUNT'S ARM COMPLETELY FROM THE PATIENT'S ARTERY. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS INCIDENT. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762484 PRUITT F3 CAROTID SHUNT CAROTID SHUNT MJN LEMAITRE VASCULAR, INC. 2012-10 UNKNOWN 00840663101214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention