BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 181644 · Received August 11, 1998

    Report

    Report Number
    3032312-1998-00098
    Event Type
    Injury
    Date Received
    August 11, 1998
    Date of Event
    July 7, 1998
    Report Date
    July 10, 1998
    Manufacturer
    THE KENDALL CO.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 07/07/1998 FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED IN A PT'S RIGHT FEMORAL ARTERY. FOLLOWING DEVICE DEPLOYMENT, OOZING WAS NOTED FROM THE PUNCTURE SITE. MANUAL PRESSURE WAS HELD WITH CONTROL OF THE BLEEDING. THE PT AMBULATED APPROXIMATELY TWO HOURS LATER, AND WAS DISCHARGED TO HOME. THREE DAYS LATER (07/10/1998) THE PT RETURNED FOR A SCHEDULED FOLLOW-UP VISIT. AT THAT TIME SHE COMPLAINED OF NUMBNESS AND TINGLING IN HER LOWER EXTREMITY. AN ULTRASOUND WAS PERFORMED WITH INCONCLUSIVE RESULTS. THE PT WAS HOSPITALIZED AND OBSERVED OVER THE WEEKEND, BUT WAS LATER DISCHARGED HOME WITHOUT SEQUELAE. ON 07/27/1998 THE PT PRESENTED TO HER PHYSICIAN WITH COMPLAINTS OF PAIN. ON 07/29/1998 AN ANGIOGRAM WAS PERFORMED WHICH IDENTIFIED A RIGHT COMMON FEMORAL ARTERIAL OCCLUSION. THE RIGHT EXTERNAL ILIAC ARTERY AND THE RIGHT FEMORAL VASCULATURE WERE NOTED TO BE SLIGHTLY COLLAPSED DUE TO DIMINISHED BLOOD FLOW. THE PT UNDERWENT SURGICAL INTERVENTION ON 08/07/1998. THE PT REPORTEDLY TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB THE KENDALL CO. NA 801705

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R