BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY

    MDR report key: 21597725 · Received March 13, 2025

    Report

    Report Number
    2015691-2025-01889
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 20, 2025
    Report Date
    April 9, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    UDI-DI
    00690103043457
    PMA / PMN Number
    K240078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AT THE FACILITY AND CANNOT BE RETURNED FOR PRODUCT EVALUATION. THE LOT NUMBER IS UNKNOWN, THEREFORE, THE DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. AN ENGINEERING EVALUATION HAS BEEN INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE ISSUE. ADDITIONAL PRODUCT CODE KRA. ADDITIONAL 510K NUMBER K892410.

    Additional Manufacturer Narrative · 0

    THERE IS NO PRODUCT EVALUATION RESULTS AS THE DEVICE WAS DISCARDED AND NOT RETURNED. WITHOUT ITS RETURN, IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS DAMAGE OR A DEFECT THAT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF ANY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS THE COMPLAINT COULD NOT BE CONFIRMED, THERE IS NOT SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. AS PART OF THE MANUFACTURING PROCESS 100 PERCENT OF THE UNITS GO THROUGH A BALLOON INSPECTION PROCESS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A FOGARTY THRU LUMEN EMBOLECTOMY VASCULAR CATHETER, WHILE THE USER WAS PULLING THE THROMBUS WITH THE INFLATED BALLOON, THE BALLOON BURST. THE TIP OF THE CATHETER BECAME BROKEN. AN ADDITIONAL INCISION WAS REQUIRED TO REMOVE THE FRAGMENTS. ALL THE FRAGMENTS COULD NOT BE COMPLETELY REMOVED. THERE WAS NO PATIENT INJURY OR COMPLICATIONS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481355 FOGARTY FOGARTY THRU LUMEN EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 12TLW403F 00690103043457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention