BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 3213892 · Received July 3, 2013

    Report

    Report Number
    2182269-2013-00054
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FINAL MEDWATCH WILL BE SUBMITTED AT THE CONCLUSION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE IN THE GROIN FOLLOWING A DIAGNOSTIC INTERVENTION. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE CARRIER TUBE COULD NOT BE PULLED BACK AND THE ANCHOR WAS STUCK IN THE ARTERY WHILE THE PT WAS STILL LYING IN THE CATH LAB CHAMBER. SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304806 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA 4021014

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R