BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2993028 · Received March 1, 2013

    Report

    Report Number
    2242445-2013-00028
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED A PORTAL VEIN THROMBOSIS WAS BEING PERFORMED ON A (B)(6) FEMALE PATIENT IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT. THE CATHETER WAS PLACED INTO THE PATIENT'S INTERNAL JUGULAR. ONE OF THE CONNECTING WIRES ON THE BASKET BECAME DETACHED WHILE IN THE PORTAL VEIN. AS A RESULT, THE PROCEDURE WAS STOPPED AND THE BASKET WAS RETRACTED INTO THE SHEATH AND REMOVED. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89153 NA PTD PRODUCTS DQY ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR