BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS THROMBOLYTIC DEVICE KIT

    MDR report key: 3972928 · Received April 28, 2014

    Report

    Report Number
    9680794-2014-00100
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ARROW INTERNACIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THIS EVENT OCCURRED IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT. THE INSERTION SITE IS UNKNOWN. THE CLINICIAN WAS PERFORMING A THROMBECTOMY, AND THE END OF THE BLACK TIP BROKE. THE CLINICIAN TRIED TO REMOVE THE BROKEN TIP FROM THE PATIENT'S BODY VIA A GUIDE WIRE. AS A RESULT A NEW KIT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AT THIS POINT, THERE IS NO INFORMATION ON WHETHER THE TIP OF THE CATHETER WAS REMOVED. IT IS REPORTED THERE WAS NO PATIENT INJURY OR COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253480 PERCUTANEOUS THROMBOLYTIC DEVICE KIT PTD PRODUCTS DXE ARROW INTERNACIONAL INC. MF3064145

    Patients

    Seq Age Sex Outcome Treatment
    1