BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 215660 · Received March 24, 1999

    Report

    Report Number
    3032312-1999-00071
    Event Type
    Injury
    Date Received
    March 24, 1999
    Date of Event
    February 23, 1999
    Report Date
    February 24, 1999
    Manufacturer
    THE KENDALL CO.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 02/17/1999 FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED IN A PATIENT'S RIGHT GROIN. FIVE (5) DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN IN THE RIGHT LEG. AN ULTRASOUND WAS PERFORMED THAT DAY WHICH APPEARED TO BE NORMAL. ON 02/23/1999 THE PATIENT AGAIN RETURNED WITH INCREASED COMPLAINTS OF PAIN AND A RIGHT PEDAL PULSE THAT WAS ONLY DOPPLERABLE. A CONTRALATERAL ANTERIOGRAM WAS PERFORMED WHICH REVEALED A VESSEL OCCLUSION. ON 02/23/1999 AN ENDARTERECTOMY REVEALED THAT THE ANGIO-SEAL ANCHOR WAS WITHIN THE VESSEL AND WAS TAKEN AWAY. ALSO NOTED WAS THAT THE VESSEL CONTAINED DENSE PLAQUE THAT WAS ADHERENT TO THE ANCHOR THAT ACTUALLY EXTENDED DOWNWARD CREATING A FLAP, AND A THROMBUS, BOTH WERE REMOVED. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R