BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYRD DILATOR SHEATH SET TEFLON

    MDR report key: 39789 · Received September 23, 1996

    Report

    Report Number
    2522007-1996-00001
    Event Type
    Injury
    Date Received
    September 23, 1996
    Date of Event
    August 28, 1996
    Report Date
    August 30, 1996
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    GCC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FILE NO. 1225

    Description of Event or Problem · 1

    WHILE EXTRACTING A CHRONIC, VENTRICULAR PACING ELECTRODE OF ANOTHER MFR VIA THE LEFT SUBCLAVIAN, A TEFLON DILATOR INNER SHEATH WAS UTILIZED INSIDE A STAINLESS STEEL DILATOR BECAUSE THE OUTER TEFLON SHEATH OF THE DILATOR SET COULD NOT BE ADVANCED DUE TO FIBRIN WITHIN THE VEIN. WHILE ATTEMPTING ADVANCEMENT OF THIS METAL OVER TEFLON DILATOR COMBINATION, A NARROW, EIGHT CENTIMETER LONG SLIVER WAS SLICED LONGITUDINALLY FROM THE TEFLON SHEATH. THE PACING ELECTRODE WAS THEN EXTRACTED USING THE FEMORAL ROUTE. THE INSULATION OF THE ELECTRODE WAS FOUND TO BE BROKEN WITH RESULTANT EXPOSURE AND DISTENSION OF THE METAL CONDUCTOR HELIX. THE PORTION OF THE TEFLON SHEATH WAS THEN SURGICALLY REMOVED FROM THE SUBCLAVIAN. THE CHEST TUBE WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BYRD DILATOR SHEATH SET TEFLON CATHETER RETRIEVAL DEVICE GCC COOK PACEMAKER CORP. LR-TEFBES 20254

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention LOCKING STYLET, 0.018" DIA.| TELESCOPING STAINLESS STEEL DILATOR SHEATH SET