BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERWAND SAFETY INTRODUCER WITH EXTENDED DWELL CATHETER

    MDR report key: 3539910 · Received November 4, 2013

    Report

    Report Number
    3009549229-2013-00001
    Event Type
    Malfunction
    Date Received
    November 4, 2013
    Date of Event
    October 25, 2013
    Report Date
    November 4, 2013
    Manufacturer
    ACCESS SCIENTIFIC LLC
    Product Code
    DYB
    PMA / PMN Number
    K131300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A THOROUGH VISUAL EXAMINATION (NAKED EYE AND UNDER MAGNIFICATION) OF THE POWERWAND INVOLVED IN THE REPORTED DEVICE MALFUNCTION WAS CONDUCTED. THE PHYSICAL EVIDENCE INDICATED: THE GUIDEWIRE WAS SEVERED PROBABLY BY THE HEEL OF THE NEEDLE'S BEVELED TIP. THE GUIDEWIRE WAS SUBJECTED TO HIGH AXIAL FORCES WHICH CAUSED THE COILED PORTION OF THE GUIDEWIRE TO UNRAVEL. THE DIRECTIONS FOR USE OF THE POWERWAND LISTS IN THE: ADVERSE EFFECTS SECTION: GUIDEWIRE EMBOLISM OR DAMAGE. CAUTIONS SECTION: DO NOT WITHDRAW THE GUIDEWIRE AGAINST THE NEEDLE BEVEL TO MINIMIZE RISK OF POSSIBLE SEVERING OR DAMAGING THE GUIDEWIRE. DO NOT FORCE FEED AND DO NOT RETRACT THE GUIDEWIRE IF RESISTANCE IS ENCOUNTERED, GUIDEWIRE SHOULD ADVANCE SMOOTHLY AND WITHOUT RESISTANCE.

    Description of Event or Problem · 1

    VASCULAR ACCESS NURSE WAS ATTEMPTING TO PLACE THE POWERWAND. AFTER THE INTRODUCER NEEDLE WAS IN THE TARGET VEIN, THE NURSE ATTEMPTED TO ADVANCE THE GUIDEWIRE INTO THE VEIN BUT IT WOULD NOT ADVANCE. THE NURSE REPEATED THIS THREE TIMES. ON THE THIRD ATTEMPT, THE PT STATED THAT IT 'HURT' WHEN THE NURSE ADVANCED THE GUIDEWIRE. AT THAT POINT, THE NURSE TRIED TO REMOVE THE ENTIRE DEVICE, BUT A PORTION OF THE GUIDEWIRE REMAINED LODGED UNDER THE SKIN. THE NURSE EXERTED MORE FORCE TO WITHDRAW THE GUIDEWIRE AND THE WIRE BROKE, LEAVING A PORTION OF IT UNDER THE SKIN. THE PT WAS TRANSPORTED TO THE INTERVENTIONAL RADIOLOGY DEPARTMENT WHERE THE IR MD RETRIEVED THE WIRE IN IT'S ENTIRETY, NO PIECE OF THE WIRE WAS SEEN UNDER FLUOROSCOPY IN THE PT'S VASCULATURE, ACCORDING TO THE IR MD (AFTER HE REMOVED THE WIRE). THE MD ADVISED THE NURSE THAT IF IN THE FUTURE IF THE NURSE ATTEMPTS TO INSERT ANY DEVICE WITH A GUIDEWIRE AND MEETS RESISTANCE, THE NURSE SHOULD REMOVE THE ENTIRE DEVICE SLOWLY TO PREVENT THE GUIDEWIRE FROM BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568197 POWERWAND SAFETY INTRODUCER WITH EXTENDED DWELL CATHETER PERIPHERAL IV CATHETER, MIDLINE DYB ACCESS SCIENTIFIC LLC 72391 164709

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DWELL CATHETER