BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MORPH ACCESSPRO STEERABLE INTRODUCER

    MDR report key: 3187796 · Received June 19, 2013

    Report

    Report Number
    MW5030645
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BIOCARDIA
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE BIOCARDIA MORPH ACCESS PRO STEERABLE INTRODUCER CAT # MAP645, LOT #01147, STARTED TO COME APART DURING A BALLOON ANGIOPLASTY OF A CELIAC AND MESENTERIC ARTERY. APPROX 1CM OF WIRE WAS EXPOSED WHEN THE DEVICE WAS REMOVED FROM THE PT. AN X-RAY AND F/U ARTERIOGRAM WAS PERFORMED TO SEARCH FOR FRAGMENTS AND LOOK FOR DAMAGE. THE X-RAYS WERE READ AS NEGATIVE FOR FRAGMENTS AND DAMAGE BY DR (B)(6). THE PT HAD SEVERELY SCARRED GROINS WHICH REQUIRED CONSIDERABLE EFFORT TO INSERT AND REMOVE THE DEVICE. THIS MAY HAVE CONTRIBUTED TO THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279404 MORPH ACCESSPRO STEERABLE INTRODUCER MORPH CATHETER, 6 FR X 45CM DYB BIOCARDIA 01147

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR