BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 4 FR X 8 CM

    MDR report key: 1000673 · Received February 15, 2008

    Report

    Report Number
    1036844-2008-00013
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REFERENCE MEDWATCH 1036844-2008-00012 FOR FIRST EVENT INVOLVING SAME PT. THIS EVENT OCCURRED FOR THE SECOND TIME WITH ANOTHER GUIDEWIRE, BUT FROM A DIFFERENT LOT NUMBER. IT WAS REPORTED THAT, VIA RIGHT SUBCLAVIAN APPROACH, THE SELDINGER GUIDEWIRE BECAME "STUCK" WHEN REMOVED FROM THE CANNULA. IMMEDIATE FLUOROSCOPIC CHECK REVEALED THE "J" TIP WAS LOCATED WITHIN THE RIGHT ATRIUM, BEHIND THE TIP OF THE CATHETER. GENTLE PULLING RESULTED IN PARTIAL UNWINDING OF THE GUIDEWIRE, SO THE SENIOR CONSULTANT WITHDREW THE CATHETER TO THE BRACHIOCEPHALIC VEIN. AS A RESULT, AFTER APPROX 15 MINS OF STRUGGLING, A PARTIALLY SEVERED GUIDEWIRE WAS REMOVED IN ONE PIECE. A THIRD KIT WAS OPENED AND SUCCESSFULLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 4 FR X 8 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF6105133

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention