BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 5139033 · Received October 8, 2015

    Report

    Report Number
    3005168196-2015-01029
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 11, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548013244
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PLEASE NOTE THAT THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2015-01026; 2. 3005168196-2015-01027; 3. 3005168196-2015-01028; 4. 3005168196-2015-01030; HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN NOTICED SIGNIFICANT TORTUOSITY AND MET RESISTANCE WHILE ADVANCING THREE DIFFERENT RUBY COILS THROUGH ANOTHER MANUFACTURER'S MICROCATHETER. THE RUBY COIL PUSHER ASSEMBLY OF ALL THREE COILS KINKED AND WERE ALL REMOVED. THE PHYSICIAN NOTICED THAT THERE WAS A KINK IN THE MICROCATHETER AND DECIDED TO SWITCH IT OUT FOR A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO NEW RUBY COILS IN THE ANEURYSM USING THE PX SLIM. HOWEVER, DURING THE LAST 2 ATTEMPTS TO DELIVER TWO NEW RUBY COILS IN THE ANEURYSM, THEY BROKE IN THE PX SLIM AND WERE SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE DID NOT CONTINUE ANY FURTHER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665653 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F63631 00814548013244

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR