BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 11845876 · Received May 18, 2021

    Report

    Report Number
    3005168196-2021-01089
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 21, 2021
    Report Date
    April 21, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548018270
    PMA / PMN Number
    K173614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 NUMBERS: 3005168196-2021-01085, 3005168196-2021-01086, 3005168196-2021-01087, 3005168196-2021-01088, 3005168196-2021-01090, 3005168196-2021-01091.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON ILIAC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, A DIAGNOSTIC CATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL (F101571) IN THE TARGET VESSEL. IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL (F94874) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT RUBY COIL (F101967) THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE RUBY COIL IN THE TARGET VESSEL. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER RUBY COIL (F100571) THROUGH THE MICROCATHETER; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN, AND THE RUBY COIL WAS REMOVED. WHILE ADVANCING THE NEXT TWO RUBY COILS (F101967 AND F98624), THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO SUCCESSFULLY IMPLANT THE TWO RUBY COILS IN THE TARGET VESSEL. IT WAS REPORTED THAT ALL THE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE RUBY COILS AROUND A CURVE. THEN, THE PHYSICIAN ADVANCED A RUBY COIL (F99601) THROUGH THE MICROCATHETER, AND WHEN TRYING TO ADVANCE THE RUBY COIL AROUND A CURVE, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO RETRACT THE RUBY COIL. HOWEVER, WHILE RETRACTING THE RUBY COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THE PHYSICIAN THEN PUSHED THE DETACHED RUBY COIL THROUGH THE MICROCATHETER WITH THE PUSHER ASSEMBLY. HOWEVER, WHILE RETRACTING THE RUBY COIL PUSHER ASSEMBLY, PART OF THE RUBY COIL STARTED TO COME BACK WITH THE PUSHER ASSEMBLY. IT WAS REPORTED THAT THE RUBY COIL SEEMED TO BE WEDGED INSIDE OF THE MICROCATHETER AND BEGAN TO UNRAVEL. THE PHYSICIAN THEN ATTEMPTED TO PUSH THE DETACHED RUBY COIL USING A NON-PENUMBRA WIRE; HOWEVER, IT WAS ALSO UNSUCCESSFUL. SUBSEQUENTLY, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE APPROXIMATELY TWO THIRDS OF THE RUBY COIL. IT WAS REPORTED THAT THE RUBY COIL BECAME MORE UNRAVELED WHILE SNARING AND THAT ONE THIRD OF THE RUBY COIL WAS LEFT IN THE TARGET VESSEL IN A GOOD LOCATION. 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
    739965 RUBY COIL HCG, KRD HCG PENUMBRA, INC. RBY4C0204-B F101967 00814548018270

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR