BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 214246 · Received March 16, 1999

    Report

    Report Number
    3032312-1999-00068
    Event Type
    Injury
    Date Received
    March 16, 1999
    Date of Event
    February 17, 1999
    Report Date
    February 17, 1999
    Manufacturer
    THE KENDALL CO.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 02/17/1999 FOLLOWING A PTCA PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED IN A PATIENT'S RIGHT GROIN.DEPLOYMENT WENT WITHOUT DIFFICULTY BUT THERE WAS AN IMMEDIATE OZING NOTED AND LIGHT MANUAL PRESSURE HELD FOR 5 MINUTES. THE TENSION SPRING WAS IN PLACE FOR 36 MINUTES, AND UPON REMOVAL, BLEEDING ONCE AGAIN STARTED. MANUAL PRESSURE HELD FOR 10 MINUES AND HEMOSTASIS ACHIEVED. AT THIS POINT THE RIGHT PEDAL PULSES WERE ONLY DOPPLERABLE. PATIENT PLACED ON HEPARIN AND INTEGRILIN INFUSION (DOSES AND DURATION UNKNOWN).ON 02/17/1999, A CARDIOVASCULAR CONSULT WAS OBTAINED AND THE PATIENT WENT TO SURGERY FOR AN EMBOLECTOMY AND REPAIR OF THE RIGHT COMMOM FEMORAL ARTERY.AS OF 03/15/1999 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 THE KENDALL CO. NA 100767

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention