BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 660220 · Received January 5, 2006

    Report

    Report Number
    2182269-2005-00235
    Event Type
    Injury
    Date Received
    January 5, 2006
    Date of Event
    November 17, 2005
    Report Date
    January 5, 2006
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A 6F STS PLUS ANGIO-SEAL VASCULAR CLOSURE DEVICE WAS USED TO SEAL THE RIGHT COMMON FEMORAL ARTERIOTOMY POST CORONARY ANGIOGRAPHY. TWENTY FOUR DAYS LATER, THE PT RETURNED FOR BILATERAL FEMORAL AND AORTA ANGIOGRAM WHICH REVEALED A FILLING DEFECT IN THE RIGHT COMMON FEMORAL ARTERY. ACCORDING TO THE REPORT, A LARGE SHORT SEGMENT FILLING DEFECT PROJECTED INTO THE COMMON FEMORAL ARTERY FROM THE ANTERIOR WALL AND RESULTED IN A 90% STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 1162737

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention