BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 137887 · Received December 12, 1997

    Report

    Report Number
    3014398-1997-00197
    Event Type
    Injury
    Date Received
    December 12, 1997
    Date of Event
    November 11, 1997
    Report Date
    November 11, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 11/05/1997 AN EMERGENCY CATHETERIZATION PROCEDURE WAS PERFORMED ON A PATIENT WHO WAS UNCONSCIOUS AND WHO HAD VERY LOW BLOOD PRESSURE (WITH SCARCELY AND PALPABLE PULSE AS A RESULT); FOLLOWING CORONARY ANGIOGRAPHY, THE PUNCTURE SITE ON THE RIGHT WAS CLOSED WITH AN ANGIO-SEAL DEVICE. ON 11/11/1997 THE PATIENT COMPLAINED OF HER RIGHT LEG BEING COLD; AN ANGIOGRAPHY WAS PERFORMED WHICH REVEALED A "NEARLY COMPLETE OCCLUSION OF THE PREVIOUS PUNCTURE SITE." IN ADDITION, NUMEROUS COLLATERAL VESSELS WERE FOUND, INDICATING WITH A HIGH DEGREE OF CERTAINTY THAT THE OCCLUSION WAS PREEXISTING DEPLOYMENT OF THE ANGIO-SEAL DEVICE; HOWEVER THE PHYSICIAN IS OF THE OPINION THAT THIS OCCLUSION MAY HAVE BEEN "INTENSIFIED, BUT NOT CAUSED, BY ANGIO-SEAL." A SECOND PROCEDURE WAS PEFORMED WITH STENT PLACEMENT IN THE OCCLUDED AREA. FOLLOWING THIS PROCEDURE THE PATIENT WAS NOTED TO BE IN GOOD CONDITION WITH PALPABLE PULSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL Implant HEMOSTATIC PUNCTURE CLOSURE DEVICE MGB SHERWOOD MEDICAL INDUSTRIES NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention