BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    MDR report key: 1922704 · Received November 12, 2010

    Report

    Report Number
    2242445-2010-00071
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THE PROCEDURE WAS BEING PERFORMED ON (B)(6) FEMALE PT. THEY WERE ATTEMPTING TO DECLOT A LEFT FOREARM LOOP GRAFT. ON (B)(6) 2010 - RECEIVED FOLLOW UP WHICH STATES THE DEVICE WAS BEING USED ON THE PT WHEN THEY NOTICED ONE OF THE WIRES ON THE BASKET BECAME DETACHED AT ONE END, BUT REMAINED INTACT. AS A RESULT, A NEW PTD DEVICE WAS OPENED AND USED TO COMPLETE THE DECLOT PROCEDURE SUCCESSFULLY. THERE WAS A FEW MINS DELAY IN TREATMENT, NO PT DEATH, AND NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7 PTD PRODUCTS DXE ARROW INTERNATIONAL INC MF0063725

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention