BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL

    MDR report key: 1081156 · Received July 10, 2008

    Report

    Report Number
    1081156
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 10, 2008
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US

    Narratives

    Description of Event or Problem · 1

    DURING THE ATTEMPTED PCI OF LAD, THE BMW GUIDE WIRE WAS PASSED THROUGH THE GUIDE CATHETER AND ACROSS THE LESION IN THE LAD. THE DOCTOR BEGAN TO PLACE THE STENT OVER THE WIRE WHEN IT WAS NOTICED THAT THE BMW WIRE HAD PULLED BACK WAS STILL IN THE LAD. THE DOCTOR REMOVED THE UN-DEPLOYED STENT AND ATTEMPTED TO RE-POSITION THE BMW WIRE. AT SOME POINT IN RE-POSITIONING, THE DOCTOR REALIZED THAT HE COULD NOT PULL THE BMW WIRE BACK. IT WAS NOT ACROSS THE LESION. IT WAS THEN NOTICED THAT APPROXIMATELY 1 CM OF THE RADIOPAQUE TIP OF THE BMW WIRE WAS VISIBLE UNDER FLUOROSCOPY. NORMALLY, 3 CM IS VISIBLE. AFTER CONSULTATION WITH ANOTHER PHYSICIAN, A BALLOON CATHETER WAS INTRODUCED AND PLACED OVER THE WIRE. THE WIRE AND BALLOON WERE THEN REMOVED WITHOUT DIFFICULTY OR INCIDENT. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY USING OTHER PRODUCTS THAN THOSE DESCRIBED ABOVE EXCEPT FOR THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDEWIRE DQX ABBOTT VASCULAR DEVICES * 8032492

    Patients

    Seq Age Sex Outcome Treatment
    1 *