BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SION BLUE

    MDR report key: 14246336 · Received April 28, 2022

    Report

    Report Number
    3004718255-2022-00256
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    April 18, 2022
    Report Date
    April 28, 2022
    Manufacturer
    ASAHI INTECC
    Product Code
    DQX
    UDI-DI
    04547327133012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT PRESENTED TO THE CATH LAB IN CARDIAC ARREST AND RESUSCITATED. DR. (B)(6) WAS WIRING THE CALCIFIED LAD WHEN THE EVENT OCCURRED. DR. (B)(6) SAID THAT THERE WAS NO RESISTANCE WHEN PULLING BACK ON THE WIRE AND IT SMOOTHLY CAME OUT LEAVING BEHIND THE TIP. THE TIP OF A SION BLUE CAME APART IN A CORONARY ARTERY. THE PATIENT WENT FOR BYPASS SURGERY AND IS DOING WELL.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED TO THE CATH LAB IN CARDIAC ARREST AND RESUSCITATED. DR. (B)(6) WAS WIRING THE CALCIFIED LAD WHEN THE EVENT OCCURRED. DR. KIM SAID THAT THERE WAS NO RESISTANCE WHEN PULLING BACK ON THE WIRE AND IT SMOOTHLY CAME OUT LEAVING BEHIND THE TIP. THE TIP OF A SION BLUE CAME APART IN A CORONARY ARTERY. THE PATIENT WENT FOR BYPASS SURGERY AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101199 SION BLUE GUIDE WIRE DQX ASAHI INTECC AHW14R104S 211206A16A 04547327133012

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention| H