BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX ANGIO-SEAL

    MDR report key: 1053038 · Received May 20, 2008

    Report

    Report Number
    1053038
    Event Type
    Injury
    Date Received
    May 20, 2008
    Date of Event
    March 18, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A PTCA WITH STENT PLACEMENT. THE ARTERY WAS CLOSED WITH A MYNX ANGIO-SEAL DEVICE. ELEVEN DAYS LATER, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH GROSS PURULENCE AND PAIN TO THE RIGHT GROIN SITE. THE PATIENT UNDERWENT RIGHT GROIN EXPLORATION, DRAINAGE OF ABSCESS, DEBRIDEMENT OF SURROUNDING TISSUES, AND VEIN PATCH REPAIR OF THE RIGHT FEMORAL ARTERY. THE CATH LAB STAFF CONTACTED THE REPRESENTATIVE, WHO INDICATED THAT HE HAD SPOKEN WITH THE CARDIOLOGIST, AND HAD PUT THE PHYSICIAN IN TOUCH WITH THE VP OF CLINICAL AFFAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ACCESSCLOSURE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R CARDIAC DRUGS| CARDIAC DRUGS