BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES

    MDR report key: 21656984 · Received March 20, 2025

    Report

    Report Number
    2024168-2025-02924
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    March 3, 2025
    Report Date
    December 15, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    DQX
    UDI-DI
    08717648013980
    PMA / PMN Number
    K950752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED NO SIMILAR COMPLAINTS FROM THIS LOT; HOWEVER, THE REPORTED LEAK / SPLASH ISSUE APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED LEAK / SPLASH APPEAR TO BE A POTENTIAL PRODUCT QUALITY ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. D9: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM YES TO NO. G4: CORRECTED PMA/510(K) # FROM K991102 TO K950752.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. DURING USE, THE COPILOT BLEEDBACK CONTROL VALVE WAS LEAKING EXCESSIVELY. THE PROCEDURE CONTINUED AND WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453801 ACCESSORIES WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR INC. 1003330 60574704 08717648013980

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown