BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY

    MDR report key: 25123483 · Received May 8, 2026

    Report

    Report Number
    2015691-2026-15007
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Report Date
    May 8, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    UDI-DI
    00690103177657
    PMA / PMN Number
    K240078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: KRA - CATHETER, CONTINUOUS FLUSH. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. 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 A PART OF THE MONTHLY REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE FOGARTY CATHETER IT FAILED TO DEFLATE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580127 FOGARTY CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES PR VASUNKNOWN NI 00690103177657

    Patients

    Seq Age Sex Outcome Treatment
    1