BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 5019534 · Received August 20, 2015

    Report

    Report Number
    3005168196-2015-00807
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548013046
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF AWARENESS LISTED WERE SUPPLIED TO PENUMBRA QUALITY BY A PENUMBRA SALES REPRESENTATIVE WHO IS NO LONGER EMPLOYED BY PENUMBRA, INC. THE HOSPITAL DOES NOT RECALL THE DATE OF THE ACTUAL EVENT AND THE DATE THE SALES REPRESENTATIVE BECAME AWARE IN UNCERTAIN. THE DATES PROVIDED ON THIS MDR ARE THE DATES SUPPLIED BY THE SALES REPRESENTATIVE. CONCLUSION: 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 MDR IS ASSOCIATED WITH MDR 3005168196-2015-00806 AND -00808. THE HOSPITAL DISCARDED THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. UPON REMOVAL FROM THE PACKAGING, THREE RUBY COILS BECAME KINKED AND WERE NOT USED IN THE PROCEDURE. THE PROCEDURE SUCCESSFULLY CONTINUED USING ANOTHER MANUFACTURER'S DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552740 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F41142 00814548013046

    Patients

    Seq Age Sex Outcome Treatment
    1