BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRUITT F3 CAROTID SHUNT

    MDR report key: 11718787 · Received April 23, 2021

    Report

    Report Number
    1220948-2021-00042
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 24, 2021
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MJN
    UDI-DI
    00840663101214
    PMA / PMN Number
    K051067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. WHEN WE INFLATED THE COMMON CAROTID BALLOON WITH 1.5CC OF WATER, WE OBSERVED THE BALLOON INFLATED SYMMETRICALLY AT ITS DISTAL LENGTH. AFTER WITHDRAWING MORE THAN 1 CC OF LIQUID, WE OBSERVED THE BALLOON FAILED TO DEFLATE SINCE BOTH OF THE INFLATION HOLES WERE COVERED BY THE BALLOON WALL AND THE BALLOON REMAINED INFLATED ON ITS DISTAL END. HOWEVER, WE WERE UNABLE TO RECREATE THE MALFUNCTION INSIDE THE TEST FIXTURE. THE BALLOON INFLATED ALONG ITS ENTIRE LENGTH AND DEFLATED PROPERLY INSIDE THE TEST FIXTURE. THE INTERNAL CAROTID BALLOON INFLATED AND DEFLATED PROPERLY. 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. OUR MANUFACTURING TEAM CONDUCT 100% INSPECTION ON EACH DEVICE AND TESTS THEM FOR BALLOON FUNCTIONALITY. EACH BALLOON IS INSPECTED TO ENSURE THEY INFLATE AND DEFLATE PROPERLY. BASED ON OUR DEVICE INVESTIGATION, THE ROOT CAUSE OF THE MALFUNCTION WAS DETERMINED TO BE AN ASSEMBLY ERROR - THE COMMON CAROTID BALLOON OF THIS SHUNT WAS POORLY ASSEMBLED WHICH LED TO THIS ISSUE. 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 US SINCE EARLY 2019. THE SURGEON OBSERVED THE MALFUNCTION DURING PRE-USE CHECK. HE THEN USED ANOTHER F3 CAROTID SHUNT FOR THE PROCEDURE.

    Description of Event or Problem · 1

    DURING PRE-USE CHECK, THE COMMON CAROTID BALLOON OF THE F3 CAROTID SHUNT FAILED TO DEFLATE COMPLETELY. DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. SURGEON THEN USED ANOTHER F3 CAROTID SHUNT FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613934 PRUITT F3 CAROTID SHUNT CAROTID SHUNT MJN LEMAITRE VASCULAR, INC. 2012-10 2012-10 00840663101214

    Patients

    Seq Age Sex Outcome Treatment
    1