BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 4842314 · Received June 12, 2015

    Report

    Report Number
    3005168196-2015-00587
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 13, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PET LOCK WAS INTACT. THE PUSHER ASSEMBLY WAS KINKED APPROXIMATELY 8.5 CM FROM THE PROXIMAL END. THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATED THAT DURING THE PROCEDURE, THE RUBY COIL WAS DROPPED ON THE FLOOR AND WAS NOT USED FURTHER. EVALUATION OF THE RETURNED DEVICE REVEALED THE PUSHER ASSEMBLY WAS KINKED. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO IMPROPER HANDLING DURING USE. IF THE DEVICE IS DROPPED ON THE FLOOR DURING USE, DAMAGE SUCH AS THIS MAY OCCUR. THESE DEVICES ARE 100% VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING PROCESS INSPECTION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE RUBY COIL WAS DROPPED ON THE GROUND, RENDERING IT UNSTERILE. THE PROCEDURE CONTINUED SUCCESSFULLY USING A NEW RUBY COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386359 RUBY COIL HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1