BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARISTOTLE 14

    MDR report key: 18141750 · Received November 15, 2023

    Report

    Report Number
    3009546466-2023-00006
    Event Type
    Injury
    Date Received
    November 15, 2023
    Date of Event
    October 10, 2023
    Report Date
    November 8, 2023
    Manufacturer
    SCIENTIA VASCULAR
    Product Code
    MOF
    UDI-DI
    00818075010011
    PMA / PMN Number
    K173235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FROM THE REVIEW OF THE MANUFACTURING LOT HISTORY RECORD, THERE IS NO INDICATION THAT THE BREAK OCCURRED DUE TO A MANUFACTURING DEFECT, AND IT DETERMINED THE LOT MET THE RELEASING CRITERIA. THERE IS NO WAY TO CONFIRM EVERY STEP TAKEN THAT COULD HAVE LED THE GUIDEWIRE TO BREAK, BUT FROM THE INFORMATION COLLECTED IN THIS INVESTIGATION, THE GUIDEWIRE APPEARS TO HAVE BENT DURING THE PROCEDURE AND THE BEND MAY HAVE BEEN FATIGUED DURING USE. THE BEND MAY HAVE BEEN FURTHER STRESSED WHEN THE PHYSICIAN TORQUED THE DEVICE AFTER IT WAS STUCK UNTIL IT BROKE. AN ATTEMPT TO SUBMIT THE EMDR WAS PERFORMED ON 08-NOV-2023, AND ON 09-NOV-2023. HOWEVER, THE ACCOUNT CERTIFICATE NEEDED TO BE PROCESSED BY THE ESG HELP DESK AND BE READY FOR USE. THIS ACTIVITY LED TO A SUBMISSION DELAY THAT WENT OVER THE 30 DAYS FDA REQUIREMENT FOR THIS TYPE OF EMDR. THE ESG HELP DESK SUGGESTED THAT THIS INFORMATION BE ENTER IN THIS TAB.

    Description of Event or Problem · 0

    ON THE 10TH OF OCTOBER 2023, SCIENTIA VASCULAR WAS NOTIFIED THAT AN ARISTOTLE 14 GUIDEWIRE (CATALOG # A14-200-002 LN:022981) BROKE DURING A PROCEDURE. THE EVENT WAS DESCRIBED AS FOLLOWS: "THE GUIDEWIRE GOT STUCK. PHYSICIAN CONTINUED TO TORQUE THE DEVICE, COULD NOT GET THE GUIDEWIRE OUT, GUIDEWIRE ENDED UP BREAKING INSIDE THE PATIENT, HOWEVER THE DOCTOR WAS ABLE TO USE A SNARE TO REMOVE THE GUIDEWIRE FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED FOR THIS EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316066 ARISTOTLE 14 GUIDEWIRE MOF SCIENTIA VASCULAR ARISTOTLE 14 022981 00818075010011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SL-10 MICROCATHETER