BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    MDR report key: 2002503 · Received January 28, 2011

    Report

    Report Number
    2242445-2011-00009
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DECLOT PROCEDURE WAS BEING PERFORMED ON A PATIENT WITH A HEAVILY CLOTTED GRAFT. AFTER SEVERAL PASSES THEY NOTICED THE ORANGE INNER LUMEN BROKE. AS A RESULT, A REGULAR PERCUTANEOUS THROMBOLYTIC DEVICE (PTD) KIT (NOT OVER-THE-WIRE) WAS OPENED AND USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN TREATMENT, NO PATIENT DEATH AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7 PTD PRODUCTS DXE ARROW INTL., INC. MF0094842

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN