BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KODAMA HD-IVUS CORONARY IMAGING CATHETER

    MDR report key: 11347796 · Received February 19, 2021

    Report

    Report Number
    11347796
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 17, 2021
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RISK MANAGEMENT WAS ALERTED BY A MEDICAL PROVIDER IN THE CATH LAB WHO RECEIVED A PRODUCT RECALL LETTER. THE PRODUCT INVOLVED IS A KODAMA HD-IVUS CATHETER (SKU/REF 017788; LOT NUMBERS 00233370, 0023337, 00233372, 00233373, 00233385). PER THE MEDICAL PROVIDER, SUCH PRODUCT WAS USED ON ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248107 KODAMA HD-IVUS CORONARY IMAGING CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ ACIST MEDICAL SYSTEMS, INC 017788 00233370, 0023337, 00233372

    Patients

    Seq Age Sex Outcome Treatment
    1