BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARISTOTLE

    MDR report key: 23699343 · Received December 2, 2025

    Report

    Report Number
    3009546466-2025-00018
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    February 20, 2023
    Report Date
    December 2, 2025
    Manufacturer
    SCIENTIA VASCULAR
    Product Code
    MOF
    UDI-DI
    00818075010134
    PMA / PMN Number
    K231954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING EVALUATION INDICATES THAT LOT NUMBER: 020197 MET THE RELEASE CRITERIA, NO ABNORMALITIES WERE FOUND ON THE GUIDEWIRE THAT WOULD INDICATE THE COREWIRE HAD SLIPPED OUT OF THE DOME, OR THAT THE BREAK COULD HAVE BEEN CAUSED BY A MATERIAL OR MANUFACTURING DEFECT. AS DISCUSSED WITH THE DOCTOR, THEY MENTIONED THAT THEY WITNESSED A KINK ON THE MICROCATHETER, THERE WAS A SHARP TURN BEFORE THE GUIDEWIRE BROKE AND STRETCHED. THERE IS NO WAY TO CONFIRM WHAT CAUSED THE GUIDEWIRE TO BREAK, DUE TO THE CONVERSATION WITH THE DOCTOR REGARDING THIS COMPLAINT, AND THE IMAGES COLLECTED DURING THE INVESTIGATION, THEY DO NOT INDICATE THAT THE GUIDEWIRE BREAK AND STRETCHING WAS DUE TO A DESIGN OR MANUFACTURING DEFECT. BECAUSE THE DOCTOR WAS ABLE TO COMPLETE THE PROCEDURE AND NO PATIENT INJURY OCCURRED, THEREFORE NO UPDATE TO THE RISK DOCUMENTATION IS NECESSARY.

    Description of Event or Problem · 0

    DURING A ANEURYSM CASE USING AN ARISTOTLE 24 (A24-200-002) GUIDEWIRE BY RADIAL ACCESS THE PHYSICIAN NOTED THE CATHETER KINKED AND THE GUIDEWIRE GOT CAUGHT AND STRETCHED. THE PHYSICIAN MENTIONED THE GUIDEWIRE PERFORMING WELL GOING INTO THE ICA AND THE GUIDEWIRE TIP WAS RESPONDING AS EXPECTED UP UNTIL THE GUIDEWIRE BROKE. THE PHYSICIAN ALSO MENTIONED THEY DECIDED TO PERFORM THE PROCEDURE THROUGH THE ARM / SHOULDER AND THAT IT WAS A TORTUOUS PATHWAY WITH A SHARP TURN AND WAS HARD TO NAVIGATE. THE PHYSICIAN LOST TIP CONTROL WHEN THEY WITNESSED THE CATHETER KINKING AND THE GUIDEWIRE STRETCHING. THE PHYSICIAN PULLED EVERYTHING OUT AND DECIDED TO SWITCH ACCESS TO THE GROIN INSTEAD USING A NEW ARISTOTLE 24. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1958744 ARISTOTLE GUIDEWIRE MOF SCIENTIA VASCULAR 00897 020197 00818075010134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MEDTRONIC PHENOM 27 CATHETER.| MEDTRONIC RIST GUIDE CATHETER.