BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 112361 · Received August 12, 1997

    Report

    Report Number
    3014398-1997-00084
    Event Type
    Injury
    Date Received
    August 12, 1997
    Date of Event
    July 8, 1997
    Report Date
    July 15, 1997
    Manufacturer
    QUINTON INSTRUMENT CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED AND HEMOSTASIS WAS IMMEDIATELY ACHIEVED. SIX HOURS POST DEVICE DEPLOYMENT AS THE PT WENT TO VOID, HE FELT A SHARP PAIN DOWN THE INSIDE OF HIS LEG (NOT AT CATHETERIZATION SITE.) THE FOLLOWING DAY, AN OFFICE VISIT WITH THE PHYSICIAN CONFIRMED A PEA-SIZED KNOT. AN ULTRASOUND WAS PERFORMED, WHICH CONFIRMED THE PRESENCE OF A 2 X 1.5 CM PSEUDOANEURYSM. ULTRASOUND GUIDED EXTERNAL MANUAL COMPRESSION WAS APPLIED, AND THE PSEUDOANEURYSM RESOLVED. F/U WITH THE PHYSICIAN LATER THAT WEEK CONFIRMED THAT THE PT WAS WITHOUT 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 800563

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention