BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1972228 · Received January 24, 2011

    Report

    Report Number
    1972228
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION, A GUIDE WIRE WAS ADVANCED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A STENT WAS ADVANCED OVER THE WIRE HOWEVER THERE WAS SIGNIFICANT RESISTANCE PASSING STENT ON THE WIRE AT THE TIP OF THE GUIDE. THIS STENT WAS REMOVED AND A SECOND STENT WAS ADVANCED. THIS STENT ALSO WAS DIFFICULT TO ADVANCE AND WAS REMOVED. WHEN THE SECOND STENT WAS REMOVED, THE DISTAL PORTION OF THE WIRE CAME OUT WITH IT. THE PROXIMAL PORTION OF THE WIRE WAS STILL IN THE PATIENT'S BODY. THE PROXIMAL PORTION WAS REMOVED WITHOUT DIFFICULTY. A NEW WIRE WAS ADVANCED IN THE LAD AND A NEW STENT WAS SUCESSFULLY PLACED AT THE LESION. THE PATIENT WAS NOT HARMED.MANUFACTURER RESPONSE FOR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE, HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE: REP IN HOSPITAL TODAY TO PICK UP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR * 0121075

    Patients

    Seq Age Sex Outcome Treatment
    1 *