BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC CATHETER

    MDR report key: 2501102 · Received March 19, 2012

    Report

    Report Number
    MW5024732
    Event Type
    Malfunction
    Date Received
    March 19, 2012
    Date of Event
    March 17, 2012
    Report Date
    March 19, 2012
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    NIE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING TRILYSIS CATHETER INSERTED BY PHYSICIAN. THE PHYSICIAN HAD THE GUIDEWIRE IN PT'S RIGHT FEMORAL VEIN AND HAD THREADED THE CATHETER OVER THE WIRE AND INTO PT'S LEG. HE THEN BEGAN WITHDRAWING THE CATHETER. INITIALLY, THERE WAS NO PROBLEM AND THEN HALF WAY OUT THERE WAS GREAT RESISTANCE. THE PHYSICIAN PULLED BOTH THE CATHETER AND WIRE OUT A SMALL AMOUNT. THEN BEGAN ATTEMPTING TO WITHDRAW THE WIRE AGAIN. HE NOTED THAT THE WIRE LOOKED AS IF IT WAS "UNCOILING." HE REALIZED THAT THE GUIDEWIRE WAS STILL NOT BUDGING FROM THE CATHETER. ANOTHER PHYSICIAN ADVISED HIM TO SLOWLY WITHDRAW BOTH CATHETER AND WIRE ENSURING THAT WIRE DID NOT RETRACT BACK INTO THE PT. HE DID SO WITHOUT INCIDENT. PT HAD NO RESULTING ISSUES. CXR AND KUB TAKEN TO ENSURE NO HARDWARE WAS LEFT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC CATHETER CATHETER NIE MEDTRONIC VASCULAR 007044 GFUJ3252

    Patients

    Seq Age Sex Outcome Treatment
    1