BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY

    MDR report key: 22984255 · Received September 5, 2025

    Report

    Report Number
    2015691-2025-07321
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 13, 2025
    Report Date
    November 17, 2025
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    UDI-DI
    00690103043518
    PMA / PMN Number
    K240078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW HAS NOT YET BEEN 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. D2B. ADDITIONAL DEVICE PRODUCT CODE: KRA- CATHETER, CONTINUOUS FLUSH. G4. ADDITIONAL PMA/510K: K892410.

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS COMPLETED. REPORT OF CATHETER BODY WAS COMPLETELY BROKEN OFF WAS CONFIRMED. CATHETER BODY WAS BROKEN AT APPROXIMATELY 4.5CM DISTAL FROM Y-ADAPTER. CROSS SURFACES OF BROKEN SECTION APPEARED UNEVEN AND ROUGH. CATHETER BODY APPEARED TO MATCH AT THE BROKEN REGION. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND NO RELATED NON-CONFORMANCES WERE FOUND. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT. PER THE IFU BALLOON RUPTURE AND CATHETER SEPARATION AS A RESULT OF EXCESSIVE PULL FORCE APPLIED TO REMOVE ADHERENT MATERIAL ARE THE MOST FREQUENT CAUSES OF REPORTED FAILURES. TO MINIMIZE THE RISK OF VESSEL DAMAGE, BALLOON RUPTURE, OR TIP DETACHMENT, DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION AND PULL FORCE FOR EACH SIZE CATHETER. ALTHOUGH THE FAILURE WAS CONFIRMED DURING PRODUCT EVALUATION IT CANNOT BE CONFIRMED AS A MANUFACTURING DEFECT. THE MANUFACTURING PROCESS HAS THE CONTROLS TO DETECT THESE CONDITIONS. SINCE, IN THESE PROCEDURES THE UNITS ARE 100% INSPECTED ACCORDING TO PLAN SPECIFICATIONS, THE BALLOON IS VISUALLY INSPECTED, FOR INFLATION AND DEFLATION, THE CATHETER IS INSPECTED FOR OBSTRUCTION OR RESTRICTED TUBE, FOR HUB / SHRINK LEAKAGE AND FOR BUSHINGS AND TIP LEAKAGE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT. 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 THIS FOGARTY CATHETER IN PATIENT; THE CATHETER BODY WAS COMPLETELY DETACHED. NO FURTHER INFORMATION WAS AVAILABLE AT THIS MOMENT. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY OR HARM ASSOCIATED WITH THE REPORTED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306910 FOGARTY CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES, PR 12TLW804F 65987823 00690103043518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown