BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7

    MDR report key: 2265962 · Received September 23, 2011

    Report

    Report Number
    2242445-2011-00126
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 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). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERCUTANEOUS THROMBOLYTIC DEVICE (PTD) WAS INSERTED WITHOUT INCIDENT. AFTER APPROX 5 PASSES, THEY FOUND THE ORANGE INNER LUMEN HAD BECOME DETACHED AT THE BASKET. AS A RESULT, A NEW KIT WAS OPENED. REFERENCE MDR#: 2242445-2011-00127

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS THROMBOLYTIC DEVICE KIT: 7 PTD PRODUCTS DXE ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK