BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 5288726 · Received December 11, 2015

    Report

    Report Number
    3005168196-2015-01274
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    November 14, 2015
    Report Date
    November 14, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548013046
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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: 1. 3005168196-2015-01272, 2. 3005168196-2015-01273. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ARTERY AROUND A PREVIOUSLY PLACED VASCULAR PLUG. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED AND DEPLOYED TWO RUBY COILS INTO THE PATIENT USING ANOTHER MANUFACTURER'S MICROCATHETER. HOWEVER, WHILE ATTEMPTING TO DELIVER A NEW RUBY COIL INTO THE PATIENT, THE RUBY COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER AND THE RUBY COIL PUSHER ASSEMBLY BECAME KINKED. THE PHYSICIAN REMOVED THE RUBY COIL AND ATTEMPTED TO DELIVER TWO NEW RUBY COILS INTO THE PATIENT. HOWEVER, THE TWO RUBY COILS WOULD NOT ADVANCE THROUGH THE MICROCATHETER AND WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THREE NEW SMALLER-SIZED AND SOFTER RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820092 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F65653 00814548013046

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR