BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2161794 · Received July 7, 2011

    Report

    Report Number
    3003681312-2011-00046
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. THE PT EXPERIENCED A PSEUDOANEURYSM AND WAS TREATED WITH AN ULTRASOUND GUIDED COMPRESSION. THE PT'S HOSPITALIZATION WAS EXTENDED DUE TO THIS EVENT. THE PT WAS REPORTED TO BE STABLE WITH NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3319348

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R