BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 119462 · Received September 12, 1997

    Report

    Report Number
    3014398-1997-00111
    Event Type
    Injury
    Date Received
    September 12, 1997
    Report Date
    August 14, 1997
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANGIO-SEAL DEVICE WAS PLACED FOLLOWING A CARDIAC CATHETERIZATION PROCEDURE; HEMOSTASIS WAS SUCCESSFULLY ACHIEVED AND THE PT WAS DISCHARGED HOME. DURING THIS PROCEDURE THE PT WAS FOUND TO HAVE NON-CRITICAL CORONARY ARTERY STENOSIS. FOLLOWING THIS CATH AND AFTER DISCHARGE HOME, THE PT DEVELOPED CLAUDICATION IN HER RIGHT LOWER EXTREMITY. NO PULSES COULD BE FELT. AN AORTOGRAM REVEALED THE SUBTOTAL OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY IN THE AREA OF THE ANGIO-SEAL PLACEMENT. IN ADDITION, THERE WAS A LONG TUBULAR-LIKE STENOTIC AREA IN THE EXTERNAL ILIAC FROM THE INGUINAL LIGAMENT UP TO (BUT NOT INCLUDING) THE AREA OF THE BIFURCATION WITH THE INTERNAL ILIAC. ON 08/25/1997 A RIGHT ILIOFEMORAL BYPASS WAS DONE WITH AN 8MM GORE-TEX GRAFT. GOOD DOPPLER PULSES WERE PRESENT IN THE COMMON, SUPERFICIAL, AND THE DEEP DERMAL SYS. THE PT TOLERATED THE PROCEDURE WELL, AND HAD PALPABLE DORSALIS PEDIS AND POSTERIOR TIBIAL PULSES POST PROCEDURE. THE PT WAS DISCHARGED HOME ON 08/29/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB QUINTON INSTRUMENT CO. NA 800799

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention