BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 217113 · Received April 5, 1999

    Report

    Report Number
    3032312-1999-00078
    Event Type
    Injury
    Date Received
    April 5, 1999
    Date of Event
    March 4, 1999
    Report Date
    March 10, 1999
    Manufacturer
    THE KENDALL CO.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 03/04/1999, FOLLOWING A DIAGNOSTIC PROCEDURE AN ANGIO-SEAL DEVICE WAS PLACED IN A PT'S RIGHT GROIN. DURING THE DEPLOYMENT THE SURGEON CUT THE SUTURE WITH COMPLETE LOSS OF TENSION, WHILE REMOVING THE TAMPER TUBE. WHEN THE POST PLACEMENT TENSION SPRING WAS REMOVED THERE WAS IMMEDIATE BLEEDING THAT COULD NOT BE CONTROLLED WITH MANUAL PRESSURE OR A C-CLAMP. THE PT WAS TAKEN TO SURGERY WHERE A THROMBECTOMY WAS PERFORMED. DURING THE SURGERY A PLAQUE FORMATION WAS NOTED ON THE POSTERIOR WALL, BUT THE ANGIO-SEAL DEVICE WAS NOT VISUALIZED. THE SURGEON THOUGHT THAT THE DEVICE WAS MOST LIKELY DEPLOYED SUBCUTANEOUSLY. THE PT WAD DISCHARGED THE NEXT DAY IN SATISFACTORY CONDITION. AS OF 04/01/1999, THERE HAS BEEN NO FURTHER REPORT TO THE MFR OF COMPLICATION OR ADD'L PT 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 100856

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R