BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 125233 · Received October 7, 1997

    Report

    Report Number
    3014398-1997-00136
    Event Type
    Injury
    Date Received
    October 7, 1997
    Date of Event
    July 11, 1997
    Report Date
    September 8, 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

    FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED IN THE RIGHT FEMORAL ARTERY, FOLLOWING WHICH LIGHT OOZING WAS NOTED. THE NEXT DAY THE PT HAD EP THROUGH THE RIGHT FEMORAL VEIN, AT WHICH TIME SEVERAL VENOUS SHEATHS WERE PLACED. THE PT WAS LATER DISCHARGED HOME; HOWEVER, TWO WEEKS LATER THE PT BEGAN EXPERIENCING CLAUDICATION AND WAS READMITTED TO THE HOSP. AN ARTERIOGRAM INDICATED FOCAL STENOSIS; ON 08/08/1997 AN EMBOLECTOMY AND ILIAC TO FEMORAL GORTEX GRAFT WERE PERFORMED. THE PT WAS LISTED AS STABLE FOLLOWING THIS PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R