BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSER 14P RX

    MDR report key: 2073624 · Received April 18, 2011

    Report

    Report Number
    2073624
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BARD
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PERIPHERAL INTERVENTION PROCEDURE, A CROSSER 14P (RX) CATHETER WAS INSERTED INTO LEFT FEMORAL ANTEGRADE APPROACH OVER GUIDEWIRE. THE CROSSER 14P (RX) CROSSED THE PROXIMAL CAP OF THE OCCLUSION WITHOUT DIFFICULTY. WHEN THE CATHETER WAS ADVANCED TO THE ANTERIOR TIBIAL ARTERY, THE INJECTOR STALLED OUT. DR. WANTED TO EXCHANGE THE CROSSER 14P (RX) FOR A NEW CATHETER. THE WIRE AND THE CATHETER WOULD NOT SEPARATE. THE WIRE APPEARED TO BE LOOPED UP IN THE ARTERY. DR. UNABLE TO REMOVE WIRE AND CATHETER THROUGH THE 6F SHEATH AFTER MULTIPLE ATTEMPTS. SURGEON NOTIFIED. AN 0.035 WIRE WAS INSERTED THROUGH THE SHEATH. THE WIRE, THE CROSSER CATHETER, AND THE 6F SHEATH WERE REMOVED. A HEMATOMA DEVELOPED. MANUAL PRESSURE APPLIED AND 7F SHEATH WAS INSERTED. CROSSER CATHETER WAS INSPECTED AND APPEARED TO BE "MELTED" TO THE WIRE, COULD NOT BE SEPARATED. PT TO THE OR FOR LEFT COMMON FEMORAL ARTERY REPAIR OF LACERATED LEFT COMMON FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSER 14P RX CATHETER, PERCUTANEOUS DQY BARD CROSSER 14P RX 33607

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention