BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 12099207 · Received July 1, 2021

    Report

    Report Number
    12099207
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 5, 2021
    Report Date
    June 22, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PENUMBRA, INC. RUBY STANDARD COIL WAS DEPLOYED INSIDE THE CATHETER. BOTH DEVICES WERE REMOVED AND A NEW SETUP OBTAINED; PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996965 RUBY COIL DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD PENUMBRA, INC. RBY2C0530-B F75931

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA