BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SSPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 8176185 · Received December 17, 2018

    Report

    Report Number
    MW5082250
    Event Type
    Injury
    Date Received
    December 17, 2018
    Date of Event
    November 12, 2018
    Report Date
    November 28, 2018
    Manufacturer
    MEDTRONIC INC/EV3 INC.
    Product Code
    NFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN ELECTIVE CARDIAC CATHETERIZATION PROCEDURE, THE FILTER BASKET OF THE SSPIDER FX BROKE OFF. RETRIEVAL ATTEMPTS FAILED. CARDIOTHORACIC INTERVENTION WAS REQUIRED TO RETRIEVE THE DEVICE. NAME AND STRENGTH: SSPIDERFX, 6. 0MMX190MM, SPD2-US-060-190.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007528 SSPIDERFX EMBOLIC PROTECTION DEVICE TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA MEDTRONIC INC/EV3 INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O| R