BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2932172 · Received January 25, 2013

    Report

    Report Number
    3003681312-2013-00005
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 2, 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
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS NOT RETURNED, OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE AND DEPLOYED INTO THE RIGHT FEMORAL ARTERY FOLLOWING A LEFT SUPERFICIAL FEMORAL ARTERY CANNULIZATION. TWO DAYS POST-DISCHARGE, THE PATIENT PRESENTED WITH REPORTED LEG/FOOT INTERMITTENT NUMBNESS. COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED AND TISSUE PLASMINOGEN ACTIVATOR WAS INFUSED FOR CLOT LYSIS. POST-INFUSION, A PIECE REMAINED WHICH WAS THOUGHT TO BE THE DEVICE ANCHOR. THE PATIENT REMAINED HOSPITALIZED FOR SEVERAL DAYS AND WILL NEED PHYSICAL THERAPY. VOLUNTARY MEDWATCH #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36100 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3661302

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R