BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 3841533 · Received May 30, 2014

    Report

    Report Number
    3005168196-2014-00351
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    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. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE USING A PENUMBRA COIL 400. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PUSH THE COIL THROUGH THE CATHETER AND INTO THE VESSEL; HOWEVER, THE COIL WOULD NO LONGER ADVANCE WHEN THE COIL REACHED THE END OF THE RENEGADE HI-FLO CATHETER. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE COIL BACK INTO THE COIL SHEATH AND THE COIL UNINTENTIONALLY DETACHED INSIDE THE RENEGADE HI-FLO CATHETER. THE PHYSICIAN THEN USED A SYRINGE TO FLUSH OUT THE DETACHED COIL INTO THE VESSEL. THIS WAS EFFECTIVE AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT AND NO ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318381 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F40548

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR