BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCIMED GUIDE WIRE

    MDR report key: 36600 · Received July 10, 1996

    Report

    Report Number
    36600
    Event Type
    Other
    Date Received
    July 10, 1996
    Date of Event
    May 17, 1996
    Report Date
    June 5, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PTCA WITH CORONARY STENTING THE SAPHENOUS VEIN BYPASS GRAFT TO THE INTERMEDIATE RAMUS BRANCH OF THE CIRCUMFLEX CORONARY ARTERY WAS REPORTEDLY STENTED X2 USING A 3.0 STENT AT THE PROXIMAL SITE AND A 3.0 STENT AT THE DISTAL SITE. REPORTEDLY, AN ATTEMPT WAS MADE TO ADVANCE A .014" STRAIGHT GUIDE WIRE DOWN THE GRAFT FOR POST DILATION OF THE DISTAL STENT. WHEN THIS WIRE WAS RETRACTED IT ALLEGEDLY BECAME ENTRAPPED AND WAS FRACTURED WITH A 2.0CM SEGMENT RETAINED WITHIN THE SAPHENOUS VEIN BYPASS GRAFT. THE PT WAS DISCHARGED 5/20/96 AFTER AN UNEVENTFUL COURSE. PT WAS READMITTED 5/21/96 WITH CVA REPORTED TO BE UNRELATED TO ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCIMED GUIDE WIRE GUIDE WIRE DQX SCIMED LIFE SYSTEMS, INC. * D18808

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other