BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE GUIDE WIRE

    MDR report key: 41989 · Received September 20, 1996

    Report

    Report Number
    41989
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Date of Event
    September 6, 1996
    Report Date
    September 16, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PTCA/STENT WAS PERFORMED ON PT IN THE CATH LAB. STENT WAS DEPLOYED IN THE PROXIMAL AREA OF A VEIN GRAFT IN THE LEFT ANTERIOR DESCENDING SAPHENOUS VEIN. A 4.0 DILATION CATHETER BALLOON WAS USED TO IMBED THE STENT. AT APPROX 6-7 ATM PRESSURE, THE BALLOON BURST AND WAS REMOVED. THE GUIDE WIRE WAS FOUND TO BE STUCK IN THE STENT AND BROKE WHEN BEING PULLED OUT. AN APPROX 1 INCH PORTION OF THE DISTAL END OF THE GUIDE WIRE WAS LEFT IN THE PT. THE WIRE WAS SECURED IN THE STENT AND WAS NOT RETRIEVABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE GUIDE WIRE GUIDE WIRE WITH MICROGLIDE COATING DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC. * 6052151

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other