BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 4241817 · Received November 10, 2014

    Report

    Report Number
    3005168196-2014-00804
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 15, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 3005168196-2014-00803. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY (SA) USING A PENUMBRA COIL 400. DURING THE PROCEDURE, AS THE INTRODUCER SHEATH WAS INSERTED INTO THE HUB OF A PX SLIM DELIVERY MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THIS RESISTANCE INCREASED AS THE PUSHER ASSEMBLY WAS PUSHED FURTHER. THE PHYSICIAN THEN REMOVED THE INTRODUCER SHEATH AND THE PENUMBRA COIL 400 FROM THE PX SLIM DELIVERY MICROCATHETER. THIS INCIDENT OCCURRED AGAIN WITH A NEW PENUMBRA COIL 400. THE PHYSICIAN CONTINUED THE PROCEDURE WITH THE SAME PX SLIM DELIVERY MICROCATHETER AND NEW PENUMBRA COIL'S 400. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723831 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC. F60345

    Patients

    Seq Age Sex Outcome Treatment
    1