BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDEWIRE

    MDR report key: 1133303 · Received August 22, 2008

    Report

    Report Number
    2024168-2008-00709
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: RESISTANCE WITH THE VESSEL REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: DIFFICULT TO REMOVE. IT WAS REPORTED THAT THE BMW GUIDE WIRE WAS PASSED THROUGH THE GUIDE CATHETER AND ACROSS THE LESION INTO THE LAD. AN ATTEMPT WAS MADE TO PLACE THE STENT OVER THE GUIDEWIRE WHEN IT WAS NOTICED THAT THE BMW GUIDE WIRE HAD PULLED BACK AND WAS STILL IN THE LAD. THE UN-DEPLOYED STENT WAS REMOVED AND ANOTHER ATTEMPT WAS MADE TO RE-POSITION THE BMW GUIDE WIRE. DURING THE RE-POSITIONING, IT WAS NOTED THAT THE BMW GUIDE WIRE COULD NOT BE PULLED OUT AND WAS NOT ACROSS THE LESION. IT WAS THEN NOTICED THAT ONLY 1 CM OF THE RADIOPAQUE TIP OF THE BMW GUIDEWIRE WAS VISIBLE UNDER FLUOROSCOPY. A BALLOON CATHETER WAS INTRODUCED AND PLACED OVER THE GUIDEWIRE AND THE BALLOON AND GUIDEWIRE WERE THEN REMOVED WITHOUT DIFFICULTY OR INCIDENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING NEW DEVICES. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDEWIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 02/28/2010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention