BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 3971914 · Received July 31, 2014

    Report

    Report Number
    3005168196-2014-00503
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 3005168196-2014-00504. HOSPITAL DISPOSED OF DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED ONE RUBY COIL. THE SECOND RUBY COIL UNINTENTIONALLY DETACHED INSIDE ANOTHER MANUFACTURER'S MICROCATHETER. THE MICROCATHETER WAS REMOVED AND FLUSHED WITH SALINE WHICH REMOVED THE COIL AND SOME THROMBUS. A NEW CATHETER WAS PLACED AND A NEW RUBY COIL WAS USED. THE PUSHER WIRE BECAME KINKED BY THE PHYSICIAN WHILE IN THE MICROCATHETER AND WAS REMOVED TO PREVENT FURTHER ERROR. THE PROCEDURE CONTINUED SUCCESSFULLY USING A NEW RUBY COIL. THERE IS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446887 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F30023

    Patients

    Seq Age Sex Outcome Treatment
    1