BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSRUE DEVICE VIP

    MDR report key: 2926270 · Received January 15, 2013

    Report

    Report Number
    3003681312-2013-00001
    Event Type
    Injury
    Date Received
    January 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. POST-DEPLOYMENT, THE PATIENT REPORTED SEVERE LEG PAIN AND CLAUDICATION AND WAS REFERRED FOR A VASCULAR CONSULT. ANTEROPOSTERIOR IMAGING REVEALED THAT THE PUNCTURE SITE WAS AT THE BIFURCATION OF THE SUPERFICIAL FEMORAL ARTERY AND THE PROFUNDA FEMORIS WITH SEVERAL SMALL BRANCHES IN THE PROXIMAL VICINITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21891 6F ANGIO-SEAL VASCULAR CLOSRUE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization