BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 120922 · Received September 17, 1997

    Report

    Report Number
    3014398-1997-00117
    Event Type
    Injury
    Date Received
    September 17, 1997
    Date of Event
    August 19, 1997
    Report Date
    August 19, 1997
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED; HOWEVER, HEMOSTASIS WAS NOT ACHIEVED. MANUAL PRESSURE WAS HELD FOR A DURATION OF 20 MINS. THE PT COMPLAINED OF NUMBNESS IN HER LEG 40 MINS FOLLOWING THE APPLICATION OF PRESSURE, AND HER PEDAL PULSES WERE NOTED TO BE ABSENT. THE PHYSICIAN SENT THE PT TO SURGERY TO RULE OUT INTRA-ARTERIAL COLLAGEN; A SMALL AMOUNT OF THROMBUS WAS NOTED AROUND THE ANCHOR AND THE COLLAGEN WAS FOUND TO BE INTRA-ARTERIAL. A FOGERTY CATHETER WAS USED TO REMOVE THE THROMBUS. THE FOLLOWING DAY THE PT WAS DISCHARGED FROM THE HOSP WITH NO FURTHER SEQUELAE.

    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 57 YR Hospitalization| R