BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE PUSH-PLUS

    MDR report key: 2802740 · Received September 18, 2012

    Report

    Report Number
    2802740
    Event Type
    Malfunction
    Date Received
    September 18, 2012
    Date of Event
    May 30, 2012
    Report Date
    September 18, 2012
    Manufacturer
    COOK MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SURGEON OBTAINED RIGHT FEMORAL ARTERIAL ACCESS USING THE MICRO PUNCTURE INTRODUCER SET. A COPE MANDRILL WIRE GUIDE WAS ADVANCED AND NOTED TO HAVE DEVELOPED A KNOT AT THE DISTAL END. THE SURGEON WAS UNABLE TO REMOVE THE WIRE GUIDE FREELY, AND HE WAS UNSURE IF THE WIRE/SLOT WAS INTRA OR EXTRA VASCULAR. ULTIMATELY, THE WIRE WAS REMOVED INTACT VIA CUT DOWN. FLUOROSCOPY WAS PERFORMED TO VERIFY NO RESIDUAL WIRE REMAINED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE PUSH-PLUS CANNULA, CATHETER DYB COOK MEDICAL * 3303199

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR