BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNADO PLATINUM EMBOLIZATION COIL

    MDR report key: 2314296 · Received October 17, 2011

    Report

    Report Number
    1820334-2011-00610
    Event Type
    Malfunction
    Date Received
    October 17, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 18, 2011
    Manufacturer
    COOK, INC.
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG # MWCE-35-4/8-TORNADO-LEF-HIRATA-061499. (B)(4).

    Description of Event or Problem · 1

    INFORMATION PROVIDED TO THE MANUFACTURER ON 12OCT2011: THE DEVICES WERE USED FOR COIL-EMBOLIZATION IN LEFT SUBCLAVIAN ARTERY. WHEN ANGIOGRAPHY WAS TAKEN AFTER COIL-EMBOLIZATION IN LEFT SUBCLAVIAN ARTERY (DIAMETER: 9MM) WITH 5 FR BALLOON CATHETER APPROACHED FROM LEFT BRACHIAL ARTERY, COIL MIGRATED. (1820334-2011-00610). THE COIL WAS PLACED IN LEFT SUBCLAVIAN ARTERY OVER ORIGIN OF VERTEBRAL ARTERY IN UNCOILED STATE. SINCE COIL MIGRATED, WHICH CREATED SPACE BETWEEN COILS, THE PHYSICIAN CONDUCTED ADDITIONAL COIL-EMBOLIZATION WITH DETACHED COIL(S) TO FILL THE SPACE. (1820334-2011-00611). AFTER THAT, RIGHT SUBCLAVIAN ARTERY-TO-LEFT VERTEBRAL ARTERY CROSSOVER WAS CONDUCTED TO SECURE BLOOD CIRCULATION. THE PATIENT HAD A FAVORABLE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNADO PLATINUM EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION VASCULAR KRD COOK, INC. NA F2616945

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention