BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR

    MDR report key: 86069 · Received July 3, 1996

    Report

    Report Number
    86069
    Event Type
    Malfunction
    Date Received
    July 3, 1996
    Date of Event
    May 7, 1996
    Report Date
    May 21, 1996
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A RIGHT & LEFT HEART CATHETERIZATION, CORONARY ANGIOGRAPHY & LEFT VENTRICULOGRAPHY WERE PERFORMED WITHOUT COMPLICATION. A ROTATIONAL ABLATION WAS PERFORMED IN THE SECOND MARGINAL BRANCH. A FLOPPY-TIPPED TYPE C WIRE (0.009) ADVANCED TO THIS BRANCH. A 1.5 MM BURR WAS PASSED ACROSS THE LESION IN MULTIPLE PASSES MAINTAINING SPEEDS BETWEEN 175,000 AND 180,000 RPM. DURING REMOVAL OF THE BURR, THE WIRE WAS ADVANCED INTO THE VERY DISTAL PORTION OF THE 2ND MARGINAL BRANCH & THE TIP FRACTURED RESULTING IN DISLODGEMENT OF THE TIP INTO THE DISTAL PORTION OF THE BRANCH. THE RETAINED WIRE TIP PORTION APPEARED STABLE IN THE DISTAL PORTION OF THE MARGINAL BRANCH. NO EXTRAVASATON OF CONTRAST AND NO COMPROMISE OF FLOW. THE PT WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDEWIRE WITH WIRECLIP TORQUER DQX HEART TECHNOLOGY, INC. * W-58918

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other