BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE CROSSER SYSTEM

    MDR report key: 2853200 · Received June 25, 2008

    Report

    Report Number
    3005007189-2008-00002
    Event Type
    Malfunction
    Date Received
    June 25, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 24, 2008
    Manufacturer
    FLOWCARDIA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A RECANALIZATION OF A PATIENT'S OCCLUDED ILIAC ARTERY, A CROSSER 14S CATHETER WAS NOTED TO BE PROLAPSING DURING USE. THE DEVICE WAS REMOVED AND INSPECTED. DURING REMOVAL, RESISTANCE WAS FELT WHEN THE TIP OF THE CROSSER 14S CATHETER WAS AT THE MOUTH OF THE INTRODUCER SHEATH. ONCE REMOVED, CASUAL INSPECTION REVEALED THE TIP OF THE CATHETER WAS MISSING. IT IS SUSPECTED THAT THE TIP OF THE PRODUCT FRACTURED DURING USE, THE SECONDARY MEASURES TO KEEP THE PRODUCT INTACT WERE CAUGHT ON THE EDGE OF THE SHEATH, THEN BROKE AS THE PHYSICIAN CONTINUED TO PULL ON THE CATHETER AND THE TIP WAS LEFT IN THE PATIENT'S LEG. IT IS ASSUMED THAT A DEVICE FRAGMENT REMAINED IN THE PATIENT, HOWEVER, NO ATTEMPT BY THE PHYSICIAN WAS MADE TO CONFIRM THIS. RECANALIZATION OF THE OCCLUDED VESSEL WAS SUCCESSFUL. THE PATIENT WAS FOLLOWED UP AT AN OFFICE VISIT ON (B)(6) 2008 AND WAS DOING WELL. THERE WAS NO EVIDENCE OR SYMPTOMS RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE CROSSER SYSTEM PERCUTANEOUS CATHETER DQY FLOWCARDIA, INC. 1374

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR