BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIO-SEL

    MDR report key: 115485 · Received August 22, 1997

    Report

    Report Number
    3014398-1997-00091
    Event Type
    Malfunction
    Date Received
    August 22, 1997
    Date of Event
    July 22, 1997
    Report Date
    July 23, 1997
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED. THE VENOUS SHEATH WAS STILL IN PLACE AT THE TIME OF ANGIO-SEAL DEPLOYMENT, WHICH IS NOT IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. PT WAS ON A HEPARIN DRIP FOR THIS PROCEDURE. THE SITE WAS IN GOOD CONDITION THROUGH THE NIGHT, AND THE PT WAS AMBULATED THE NEXT DAY WITHOUT DIFFICULTY. THE NEXT EVENING, THE PT EXPERIENCED A RIGHT GROIN BLEED. MANUAL PRESSURE WAS HELD FOR 15 MINS, AND A PRESSURE DRESSING WAS APPLIED. HEMOSTASIS WAS AGAIN ACHIEVED: THERE WAS NO HEMATOMA, AND THE PT'S PULSES WERE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB QUINTON INSTRUMENT CO. NA 800736

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR