BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 7195535 · Received January 16, 2018

    Report

    Report Number
    3005168196-2018-00138
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    November 8, 2017
    Report Date
    December 18, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2018-00137 AND 3005168196-2018-00139.

    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 PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2018-00137, 2. 3005168196-2018-00139. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH TWO SMART COILS USING THE HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39006 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR