BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 5289981 · Received December 11, 2015

    Report

    Report Number
    3005168196-2015-01261
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 11, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015194
    PMA / PMN Number
    K151572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED FROM "K120330" TO K151572. 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. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING PREPARATION FOR THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH ANOTHER MANUFACTURER'S MICROCATHETER, THE TECHNICIAN AND PHYSICIANS FELT "GRITTINESS" OR "ROUGHNESS" AND DECIDED NOT TO ADVANCE THE COIL ANY FURTHER. THE SMART COIL NEVER CAME INTO CONTACT WITH THE PATIENT AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820761 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. F65993 00814548015194

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR