BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSEAL

    MDR report key: 288497 · Received July 26, 2000

    Report

    Report Number
    MW1019431
    Event Type
    Injury
    Date Received
    July 26, 2000
    Date of Event
    June 21, 2000
    Report Date
    July 26, 2000
    Manufacturer
    SHERWOOD MEDICAL
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIAGNOSTIC CARDIAC CATH COMPLETE. RIGHT FEMORAL ARTERY ANGIOGRAPHY TAKEN. SMALL 2 1/2 CM HEMATOMA NOTED AT SHEATH SITE. PHYSICIAN AWARE. 6F SHEATH EXCHANGED OVER WIRE W/ANGIOSEAL SHEATH W/OUT DIFFICULTY. ATTEMPTED TO ADVANCE CARRIER TUBE. TUBE ADVANCED UNTIL BLUE MARKERS MET BUT WOULD NOT ADVANCE ANY MORE. ATTEMPTED TO REMOVE CARRIER TUBE TO REINSERT WIRE AND CHANGE OUT SYSTEMS. COLLAGEN WET, WOULD NOT ALLOW REMOVAL OF CARRIER TUBE. SHEATH REMOVED. MANUAL PRESSURE HELD FOR 20 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL VASCULAR SEALING DEVICE MGB SHERWOOD MEDICAL * 00 AW05

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention