BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

    MDR report key: 3093808 · Received April 30, 2013

    Report

    Report Number
    1036844-2013-00159
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE RIGHT INTERNAL JUGULAR OF A FEMALE PT IN THE EMERGENCY DEPT. AT THE TIME OF THE EVENT THEY WERE USING THE DILATOR AND GUIDE WIRE. WHEN THEY WERE REMOVING THE GUIDE WIRE, IT FRAYED AND THE INNER CORE WIRE CAME OUT OF THE SKIN INCISION AND THE OUTER COILED PORTION APPEARED TO BE TETHERED. THE PHYSICIAN STATED WHEN THE GUIDE WIRE FRAYED UPON INITIAL EXTRACTION, HE HAD THE OUTER COILED PORTION CLAMPED AT THE SKIN INCISION SITE WITH A KELLY CLAMP IN AN ATTEMPT TO SEND THE PT TO CT SCAN AND ASCERTAIN THE OUTER COIL'S POSITION. UPON REMOVING THE STERILE DRAPE, THE OUTER COIL SNAPPED OFF AT THE SKIN RIGHT BELOW THE KELLY CLAMP POINT. THE POSITION OF THE OUTER COIL WAS SEEN ON CT SCAN TO EXTENDED DOWN TO THE PT'S INFERIOR VENA CAVE FILTER. THE PT WAS SENT TO THE ICU IN A CERVICAL COLLAR AND CARDIOVASCULAR SURGEON EVAL FOR EXTRACTION OF THE REMAINING PORTION OF THE GUIDE WIRE. F/U INFO FROM RISK MGMT STATES THE RETAINED WIRE WAS REMOVED FROM THE PT THE FOLLOWING DAY BY AN INTERVENTIONAL RADIOLOGIST WITHOUT COMPLICATIONS. THE PT DID WELL POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186683 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 ARROWG+ARD CATHETER PRODUCTS. FOZ ARROW INTL., INC. RM2084591

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention