BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT ASPIRATION CATHETER

    MDR report key: 2800047 · Received October 17, 2012

    Report

    Report Number
    1721504-2012-00165
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 22, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DXE
    PMA / PMN Number
    K100569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVAL. THE USER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. THE EVAL IS IN PROCESS. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT AFTER ASPIRATION OF A CLOT FROM THE DISTAL SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MARGINAL ARTERY (OM) THE CATHETER COULD NOT BE WITHDRAWN. THE CATHETER AND GUIDE WIRE WERE STUCK TOGETHER. THE PHYSICIAN WAS REQUIRED TO REMOVE THE GUIDE WIRE AND CATHETER. THE PHYSICIAN INSERTED A NEW GUIDE WIRE AND A BALLOON CATHETER, AND COMPLETED THE PROCEDURE WITHOUT COMPLICATION. NO HARM OR INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT ASPIRATION CATHETER CATHETER, EMBOLECTOMY DXE MERIT MEDICAL SYSTEMS, INC. H381059

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: MEDTRONIC LCB 7F| GUIDE WIRE: 0.014 3 ASAHI PROWATER