BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZUR DETACHABLE 35 SYSTEMS

    MDR report key: 4780759 · Received May 15, 2015

    Report

    Report Number
    2032493-2015-00067
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 17, 2015
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE IMPLANT COIL AND DELIVERY PUSHER WERE RETURNED. THE COIL AND PUSHER REVEAL EVIDENCE OF STRETCHING, COIL DETACHMENT IS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    COILING TREATMENT WAS CONDUCTED OF A VESSEL. UPON POSITIONING THE COIL, IT PREMATURELY DETACHED WITHIN THE CATHETER. THE COIL AND CATHETER WERE REMOVED TOGETHER. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318086 AZUR DETACHABLE 35 SYSTEMS EMBOLIZATION COIL KRD MICROVENTION, INC. 45-450415 13122112

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR