BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERC. THROMBOLYTIC DEVICE KIT

    MDR report key: 2483508 · Received March 5, 2012

    Report

    Report Number
    2242445-2012-00041
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 5, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, IN ANGIO WHILE THE PROCEDURE WAS IN PROGRESS, THE TIP OF THE CATHETER DETACHED LEAVING IT IN THE PT'S BODY. AS RESULT, THE PROCEDURE WAS IMMEDIATELY STOPPED AND THE TIP WAS SURGICALLY REMOVED. AFTER THE TIP REMOVAL, AS THE PROCEDURE WAS ALMOST COMPLETE, THE MD DECIDED TO REMOVE THE REMAINING THROMBOSIS AND THE PT WAS DOING FINE. IT WAS NOTED THAT THE MD WAS SKILLED WITH THE PTD SYSTEM AND FOLLOWED THE INSTRUCTIONS FOR USE. A DELAY WAS REPORTED, HOWEVER, THERE WAS NO DEATH OR COMPLICATIONS AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERC. THROMBOLYTIC DEVICE KIT PTD PRODUCTS DXE ARROW INTL., INC. MF1105081

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention