BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE INTRODUCER SHEATH

    MDR report key: 34810 · Received July 23, 1996

    Report

    Report Number
    1219544-1996-00015
    Event Type
    Injury
    Date Received
    July 23, 1996
    Date of Event
    June 17, 1996
    Report Date
    July 10, 1996
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS DISTRIBUTOR BECAME AWARE ON 7/10/96 OF AN EVENT THAT OCCURRED INVOLVING AN INTRODUCER SHEATH WHILE PERFORMING AN ILIAC RUN OFF PROCEDURE. THE GUIDEWIRE FROM THE INTRODUCER KIT WAS ADVANCED THROUGH AN ENTRY NEEDLE INTO THE FEMORAL ARTERY. AS THEY WERE ADVANCING THE WIRE THE C-ARM LOST POWER. A PORTION OF THE WIRE BROKE AND DETACHED IN THE PT'S GROIN. AN INCISION WAS MADE AND HEMOSTATS WERE USED TO SUCCESSFULLY RETRIEVE THE SEGMENT WHICH WAS APPROX 5 CM IN LENGTH. FOLLOW-UP FROM THE USER FACILITY SUGGESTS TWO OPTIONS MAY HAVE OCCURRED. THE GUIDEWIRE MAY HAVE ENTERED A NATIVE VESSEL WHERE A BYPASS GRAFT HAD BEEN AND THE WIRE MAY HAVE CAUGHT ON CALCIFICATION. OTHER FOLLOW-UP SUGGESTS THE WIRE BROKE WHEN PULLING IT OUT OF THE ENTRY NEEDLE. THE PT EXPERIENCED NO SEQUELAE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE INTRODUCER SHEATH INTRODUCER SHEATH DYB TERUMO MEDICAL CORP. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention