BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERICARDIOCENTESIS PROCEDURE KIT

    MDR report key: 715666 · Received October 6, 2005

    Report

    Report Number
    1628221-2005-00023
    Event Type
    Malfunction
    Date Received
    October 6, 2005
    Date of Event
    September 13, 2005
    Report Date
    September 13, 2005
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PERICARDIOCENTESIS PROCEDURE, THE PHYSICIAN INSERTED AN .038" GUIDE WIRE THROUGH AN 18GX15CM NEEDLE, WHICH WAS ALREADY INSERTED IN THE PT'S PERICARDIAL SAC. RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE NEEDLE OVER THE GUIDE WIRE. THE DILATOR WAS INSERTED OVER THE GUIDE WIRE WITHOUT ANY COMPLICATION. UPON INSERTION OF THE DRAINAGE CATHETER, RESISTANCE WAS MET, AND THE CATHETER REMAINED "STUCK" ON THE MIDDLE OF THE GUIDE WIRE. UPON ATTEMPTING TO REMOVE THE GUIDE WIRE, RESISTANCE WAS ENCOUNTERED, AND BOTH THE CATHETER AND GUIDE WIRE WERE PULLED OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER PERICARDIOCENTESIS KIT. THERE WAS NO REPORTED SHORT-TERM OR PERMANENT PT IMPAIRMENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERICARDIOCENTESIS PROCEDURE KIT .038 GUIDE WIRE, 6F PIGTAIL DRAINAGE CATHETER DOR MERIT MEDICAL SYSTEMS, INC. NA F394727

    Patients

    Seq Age Sex Outcome Treatment
    1 *