BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 3982166 · Received August 5, 2014

    Report

    Report Number
    3005168196-2014-00510
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 3005168196-2014-00508 AND 00509. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE TECHNICIAN ATTEMPTED TO ADVANCE A RUBY COIL AGAINST RESISTANCE AND THE PUSHER WIRE BECAME BENT. THE CATHETER WAS REMOVED AND THE COIL WAS DISCARDED. A NEW RUBY COIL WAS USED. WHILE REMOVING A SECOND RUBY COIL FROM ITS PROTECTIVE HOOP, THE PUSHER WIRE BECAME BENT AND WAS NOT USED. A THIRD RUBY COIL WAS REMOVED FROM INVENTORY AND WHILE REMOVING IT FROM ITS PROTECTIVE HOOP, THE PUSHER WIRE BECAME BENT AND WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457181 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F42981

    Patients

    Seq Age Sex Outcome Treatment
    1