BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAP ASPIRATION CATHETER

    MDR report key: 2860226 · Received November 21, 2012

    Report

    Report Number
    1721504-2012-00187
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXE
    PMA / PMN Number
    K100569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL - THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVAL. THE USER DID NOT INDICATE IF THIS WAS THE INITIAL USE OF THE DEVICE AND DID NOT PROVIDE A LOT NUMBER. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A THROMBUS ASPIRATION PROCEDURE, THE DEVICE BECAME STUCK IN THE GUIDING CATHETER AFTER THE ASPIRATION HAD BEEN PERFORMED. ONLY 5 CM OF THE DEVICE WERE OUTSIDE THE GUIDING CATHETER. THE PHYSICIAN HAD TO REMOVE THE GUIDE WIRE, ASPIRATION CATHETER, AND GUIDING CATHETER TOGETHER FROM THE PT. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAP ASPIRATION CATHETER CATHETER, EMBOLECTOMY DXE MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1