BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY

    MDR report key: 21355569 · Received February 11, 2025

    Report

    Report Number
    2015691-2025-00923
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    November 15, 2024
    Report Date
    March 13, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    UDI-DI
    00690103177657
    PMA / PMN Number
    K240078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AT THE FACILITY AND IS NOT AVAILABLE FOR RETURN AND PRODUCT EVALUATION. THE INSTRUCTIONS FOR USE (IFU) WARNS "THE POSSIBILITY OF BALLOON RUPTURE MUST BE TAKEN INTO ACCOUNT WHEN CONSIDERING THE RISKS INVOLVED IN ANY EMBOLECTOMY PROCEDURE. TO MINIMIZE THE RISK OF VESSEL DAMAGE, BALLOON RUPTURE, OR TIP DETACHMENT, DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION VOLUME AND PULL FORCE FOR EACH SIZE CATHETER." THE IFU ALSO INSTRUCTS THE CUSTOMER TO INSPECT THE CATHETER WITH THE BALLOON INFLATED DURING PURGING. THE DEVICE HISTORY RECORD REVIEW IS PENDING. ONCE THE RESULTS ARE AVAILABLE, THEY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. ADDITIONAL PRODUCT CODE, KRA. ADDITIONAL 510K NUMBER, K892410. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE FACILITY SUBMITTED A VOLUNTARY MEDWATCH, MW5164423.

    Additional Manufacturer Narrative · 0

    THERE IS NO PRODUCT EVALUATION 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. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON CONFORMANCES.

    Description of Event or Problem · 0

    AS REPORTED, THERE WAS A FAILURE WITH A FOGARTY EMBOLECTOMY CATHETER. DURING USE, THE SURGEON INSERTED THE FOGARTY CATHETER THROUGH THE BRONCHOSCOPE INTO THE PATIENT'S CHEST CAVITY. WHEN THE BALLOON WAS ATTEMPTED TO BE INFLATED, THE SURGEON REALIZED THE BALLOON HAD POPPED. BIOPSY FORCEPS WERE USED TO RETRIEVE THE BALLOON, HOWEVER, THERE WERE NO BALLOON REMNANTS FOUND. THERE IS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959519 FOGARTY FOGARTY THRU LUMEN EMBOLECTOMY CATHETER 3F 120CM DXE EDWARDS LIFESCIENCES 12TLW1203F 65650510 00690103177657

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male