BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE

    MDR report key: 383025 · Received March 19, 2002

    Report

    Report Number
    2182269-2002-00017
    Event Type
    Injury
    Date Received
    March 19, 2002
    Date of Event
    February 17, 2002
    Report Date
    March 19, 2002
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A ROUTINE ANGIOPLASTY TO THE RIGHT CORONARY ARTERY OF A PATIENT WITH A HISTORY OF ACUTE ANTERIOR MYOCARDIAL INFARCTION (2001) AND NON-INSULIN DEPENDENT DIABETES MELLITUS, THE 6F ANGIO-SEAL WAS DEPLOYED WITH NO COMPLICATIONS AND THE PATIENT WAS ROUTINELY DISCHARGED. THE PT HAD RECEIVED A BOLUS DOSE OF REO-PRO PRIOR TO THE PROCEDURE. IN 2002, ONE WEEK LATER, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH AN INFECTED PUNCTURE SITE. THE WOUND CULTURE REVEALED STAPHYLOCOCCUS. SURGICAL INTERVENTION WAS PERFORMED TO INCLUDE REMOVAL OF THE ANGIO-SEAL DEVICE FOLLOWED BY DEBRIDEMENT AND REPAIR OF THE ARTERY. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED. THE PATIENT RECOVERED AND WAS DISCHARGED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE 6F ANGIO-SEAL MILLENNIUM MGB ST. JUDE MEDICAL, DAIG DIVISION, INC. NA 01EG31

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention IV ANTIBIOTICS.