BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL

    MDR report key: 99231 · Received June 18, 1997

    Report

    Report Number
    3014398-1997-00030
    Event Type
    Injury
    Date Received
    June 18, 1997
    Date of Event
    February 14, 1997
    Report Date
    May 20, 1997
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING AN RCX STENT PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED, AND HEMOSTASIS WAS COMPLETE AND IMMEDIATE. ON AMBULATION, THE PT WALKED A SHORT DISTANCE (50 METERS) BEFORE CLAUDICATION WAS NOTED. PERIPHERAL ANGIOGRAPHY SHOWED NEW HIGH GRADE STENOSIS OF THE COMMON FEMORAL ARTERY. THERE WAS ENOUGH RESIDUAL COLLATERAL FLOW THAT SURGERY WAS NOT ATTEMPTED. THE PT WAS TREATED WITH ANTICOAGULATION. ON FOLLOW-UP AT FOUR WEEKS, PT CONTINUES WITH CLAUDICATION, ALTHOUGH IT IS BETTER THAN IT WAS ACUTELY. THE POSTERIOR TIBIAL ARTERY IS OCCLUDED, BUT COLLATERAL FLOW REMAINS GOOD. ON FOLLOW-UP ON 6/4/97, ALL SYMPTOMS HAD RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention