BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 11966108 · Received June 9, 2021

    Report

    Report Number
    3005168196-2021-01283
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 11, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548018553
    PMA / PMN Number
    K173614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-01284.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT FOURTH LUMBAR ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THE LUMBAR ARTERY WAS VERY TORTUOUS, MAKING WHAT APPEARED TO BE CLOSE TO 90 DEGREES BEND BEFORE THE INTENDED LANDING ZONE. DURING THE PROCEDURE, A RUBY COIL (F103384) WOULD NOT FULLY EXIT THE MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, THE NEXT RUBY COIL (F101241) WOULD ONLY PARTIALLY EXIT THE MICROCATHETER, AND THE COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF A NON-PENUMBRA COIL TO PUSH THE COIL WHERE THE PHYSICIAN WANTED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860685 RUBY COIL HCG, KRD HCG PENUMBRA, INC. RBY2C0312-B F103384 00814548018553

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR