BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2161795 · Received July 7, 2011

    Report

    Report Number
    3003681312-2011-00047
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    May 9, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT 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 PHYSICIAN ALLEGES THAT THE DEVICE WAS DEPLOYED AS NORMAL, BUT THE COLLAGEN WAS VISIBLE ABOVE THE SKIN SURFACE. THE PHYSICIAN MANAGED TO MANIPULATE THE COLLAGEN UNDER THE SKIN. HEMOSTASIS WAS ACHIEVED WITH SOME OOZING NOTED. A HEMATOMA DEVELOPED, CAUSING THE PT'S HOSPITAL STAY TO BE EXTENDED BY TWENTY-FOUR HOURS. THE PT WAS REVIEWED BY THE PHYSICIAN AND IS SAID TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP MGB ST. JUDE MEDICAL NA 3257944

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization