BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 215624 · Received March 24, 1999

    Report

    Report Number
    3032312-1999-00072
    Event Type
    Injury
    Date Received
    March 24, 1999
    Date of Event
    February 23, 1999
    Report Date
    February 25, 1999
    Manufacturer
    THE KENDALL CO
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 02/23/1999 FOLLOWING A STENT PLACEMENT AN ANGIO-SEAL DEVICE WAS PLACED IN A PATIENT'S RIGHT GROIN. THE DEPLOYMENT WAS WITHOUT DIFFICULTY; HOWEVER, THERE WAS IMMEDIATE BLEEDING WITH THE FORMATION OF A HEMATOMA THAT REQUIRED APPLICATION OF MANUAL PRESSURE FOLLOWED BY A FEMOSTOP (DURATION UNKNOWN). APPROX TWO MINUTES POST-DEPLOYMENT THE VENOUS SHEATH WAS REMOVED, WITH CONTINUING GROWTH OF THE HEMATOMA. THE HEMOGLOBIN DROPPED FROM 11 TO 7.5 OVER THE NEXT FEW HOURS, REQUIRING A TRANSFUSION (TYPE AND AMOUNT UNKNOWN). THE PATIENT WAS TAKEN TO SURGERY WERE AN EXPLORATION OF THE RIGHT GROIN FOUND A 3 CM PSEUDOANEURYSM AND TRIPLE STICKS INTO THE ARTERY; ALL WERE REPAIRED. THE PATIENT WAS DISCHARGED 2 DAYS AFTER SURGERY. AS OF 03/23/1999 THERE HAS BEEN NO FURTHER REPORT TO THE MANUFACTURER 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 801927

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention