BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTAR XL 8 FR PVS

    MDR report key: 279583 · Received May 24, 2000

    Report

    Report Number
    2953144-2000-00082
    Event Type
    Injury
    Date Received
    May 24, 2000
    Date of Event
    April 11, 2000
    Report Date
    April 28, 2000
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT ANGIOPLASTY AND STENTING OF A LEFT COMMON CAROTID ARTERY STENOSIS. THE RADIOLOGIST ATTEMPTED CLOSURE OF THE ARTERIOTOMY SITE WITH A PROSTAR PXL 8FR DEVICE. TWO OF THE FOUR NEEDLES FAILED TO PRESENT. DURING REMOVAL OF THE DEVICE, THE RIGHT FEMORAL ARTERY WAS LACERATED RESULTING IN SIGNIFICANT BLOOD LOSS BEFORE HEMOSTASIS COULD BE ACHIEVED. THE PT WAS TAKEN FOR A SUCCESSFUL REPAIR OF THE RIGHT FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL 8 FR PVS PERCUTANEOUS VASCULAR SURGICAL MGB NA 6371

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED.