BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS

    MDR report key: 506980 · Received January 16, 2004

    Report

    Report Number
    3003681312-2004-00002
    Event Type
    Injury
    Date Received
    January 16, 2004
    Date of Event
    December 17, 2003
    Report Date
    January 16, 2004
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A CORONARY STENT PLACEMENT, AN ANGI0-SEAL DEVICE WAS DEPLOYED TO SEAL THE ARTERIOTOMY SITE. THE PT PRESENTED TO THE HOSP APPROX 48-72 HOURS LATER AND WAS DIAGNOSED WITH A HEMATOMA, INFECTION, AND CELLULITIS AT THE PREVIOUS ACCESS SITE. THE PT WAS TREATED WITH ANTIBIOTICS AND WAS DISCHARGED IN 12/2003 WITHOUT A HEMATOMA, SIGNS/SYMPTOMS OF INFECTION, OR CELLULITIS. THE PT WAS REPORTEDLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS 6F ANGIO-SEAL STS DEVICE MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 03DJ16

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention IV ANTIBIOTICS, TYPE, DOSE UNKNOWN. STARTED 2003.| DOXICYCLINE 250 MG. EVERY 6 HOURS FOR 10 DAYS,| STARTED 2003.| VICODIN, DATES, DOSE UNK.