BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULLAN PERCUTANEOUS TRIGEMINAL GANGLION MICROCOMPRESSION SET

    MDR report key: 1247086 · Received November 24, 2008

    Report

    Report Number
    1247086
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    November 18, 2008
    Report Date
    November 24, 2008
    Manufacturer
    COOK VASCULAR, INC.
    Product Code
    HAO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE WITH BALLOON COMPRESSION, THREE SETS WERE OPENED AND USED ON THE FIELD. HOWEVER, THE BALLOONS POPPED WITH EACH SET. A DIFFERENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULLAN PERCUTANEOUS TRIGEMINAL GANGLION MICROCOMPRESSION SET KIT, CATHETER, BALLOON HAO COOK VASCULAR, INC. G26573 N75761
    2 MULLAN PERCUTANEOUS TRIGEMINAL GANGLION MICROCOMPRESSION SET KIT, CATHETER, BALLOON HAO COOK VASCULAR INC. G26573 N77526
    3 MULLAN PERCUTANEOUS TRIGEMINAL GANGLION MICROCOMPRESSION SET KIT, CATHETER, BALLOON HAO COOK VASCULAR INC. G26573 N77046

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR