BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS MINI STICK MAX

    MDR report key: 5952310 · Received September 13, 2016

    Report

    Report Number
    MW5064763
    Event Type
    Injury
    Date Received
    September 13, 2016
    Date of Event
    August 26, 2016
    Report Date
    September 1, 2016
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    DRE
    UDI-DI
    H965457590
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ATTEMPTED PERIPHERAL ARTERY ANGIOPLASTY OF LEFT FEMORAL ARTERY, WAS ACCESSED UTILIZING THE MICROPUNCTURE TECHNIQUE. IT WAS DIFFICULT TO PLACE THE MICROPUNCTURE SHEATH OVER THE GUIDEWIRE INTO VESSEL. THE GUIDEWIRE ACTUALLY BROKE WITH PART BEING RETAINED IN THE ILIAC ARTERY. THE COMMON FEMORAL ARTERY WAS RE-ACCESSED BY GAINING ENTRY INTO THE VESSEL. A 4-FRENCH ANGLED GLIDE CATHETER AND A 2MM MICRO SNARE KIT WAS USED TO RETRIEVE THE BROKEN WIRE. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597217 ANGIODYNAMICS MINI STICK MAX MINISTICK MAX DRE NAVILYST MEDICAL, INC. 5061463 H965457590

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR