BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL VASCULAR DEVICE

    MDR report key: 3862738 · Received June 2, 2014

    Report

    Report Number
    3862738
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT HEART CATH WITH PTCA PROCEDURE ON (B)(6) 2014. ANGIO SEAL DEVICE WAS DEPLOYED AT THE END OF THE PROCEDURE. PT REPORTEDLY FELT A POP WHEN HE MOVED LATER THAT DAY AND STARTED TO HAVE GROIN PAIN AFTERWARDS. PT UNDERWENT SURGICAL REPAIR OF HIS RIGHT COMMON FEMORAL ARTERY AND THROMBECTOMY OF THE RIGHT COMMON FEMORAL AND SUPERFICIAL VEIN. THE ANGIO-SEAL DEVICE WAS IDENTIFIED AND REMOVED APPROXIMATELY 2 CM ABOVE THE AREA AND IT WAS NOT INTRA-ARTERIAL. THE ENTIRE ANGIO-SEAL WAS REPORTED AS BEING INTACT IN THAT LOCATION. PT LATER DEVELOPED DVT WITHIN THE RIGHT COMMON FEMORAL VEIN AND THROMBUS WITHIN THE GREATER SAPHENOUS SYSTEM. HE UNDERWENT TPA THROMBOLYSIS AND AN INFERIOR VENA CAVA FILTER WAS PLACED. HE ALSO UNDERWENT DEBRIDEMENT OF HIS RIGHT GROIN WOUND WITH PLACEMENT OF A WOUND V.A.C. AND WAS DISCHARGED HOME WITH HOME HEALTH FOR WOUND V.A.C. CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322402 ANGIO-SEAL VASCULAR DEVICE VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL REF: C610135 4317250

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| O| R