BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERC. THROMBOLYTIC DEVICE KIT

    MDR report key: 2201457 · Received August 3, 2011

    Report

    Report Number
    2242445-2011-00104
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 29, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED IN INTERVENTIONAL RADIOLOGY ON A THROMBOSED/CLOTTED GRAFT IN THE PATIENT'S ARM. THE PATIENT WAS GIVEN A LOCAL AND HEPARIN. AFTER ABOUT 2 TO 3 PASSES, ONE OF THE WIRES ON THE BASKET DISLODGED FROM THE TIP OF THE CATHETER. AS A RESULT, THE DEVICE WAS REMOVED AND A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY IN TREATMENT WITH NO HARM TO THE PATIENT, NO PATIENT DEATH AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT RECEIVED A SUCCESSFUL DECLOT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK