BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    MDR report key: 2002502 · Received January 28, 2011

    Report

    Report Number
    2242445-2011-00007
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 14, 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). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 SECOND KIT WAS OPENED. THERE WERE NO SHARP ANGLES ENCOUNTERED. THERE WAS NO DELAY IN TREATMENT, NO PATIENT DEATH AND NO PATIENT COMPLICATIONS REPORTED. THE PATIENT OUTCOME WAS FINE. REFERENCE MDR #2242445-2011-00008 FOR THE SECOND EVENT INVOLVING THE SAME PATIENT.

    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