BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 222050 · Received May 7, 1999

    Report

    Report Number
    3032312-1999-00098
    Event Type
    Injury
    Date Received
    May 7, 1999
    Date of Event
    April 9, 1999
    Report Date
    April 9, 1999
    Manufacturer
    DAIG, A ST. JUDE MEDICAL CO.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 04/09/1999 FOLLOWING A DIAGNOSTIC PROCEDURE AN ANGIO-SEAL DEVICE WAS PLACED IN A PATIENT'S RIGHT GROIN. REPORTEDLY THE PHYSICIAN HAD DIFFICULTY WITH THE DEPLOYMENT. ALMOST IMMEDIATELY POST-DEPLOYMENT THE PATIENT WAS NOTED TO HAVE A "BLUE FOOT", AND MANUAL PRESSURE WAS REQUIRED FOR PERSISTENT BLEEDING. THE PATIENT WAS TAKEN TO SURGERY WHERE THE DEVICE WAS REMOVED AND A LACERATION TO THE FEMORAL ARTERY WAS IDENTIFIED AND REPAIRED. AS OF 04/06/1999, THERE HAS BEEN NO FURTHER REPORT TO THE MANUFACTURE OF COMPLICATION OR ADDITIONAL PATIENT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB DAIG, A ST. JUDE MEDICAL CO. NA 101533

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention