BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2792335 · Received October 12, 2012

    Report

    Report Number
    3003681312-2012-00062
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTION THAT A PSEUDOANEURYSM IS A POSSIBLE RISK ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS DEPLOYED FOLLOWING AN ANGIOGRAM ACCESSED FROM THE RIGHT FEMORAL ARTERY. AS THE DEVICE CAP WAS BEING PULLED BACK TO COMPLETE DEPLOYMENT, A SMALL AMOUNT OF BLOOD SPURTED FROM THE PUNCTURE SITE. THE BLEEDING IMMEDIATELY STOPPED WHEN DEVICE WAS FULLY PULLED BACK AND THE TAMPER TUBE WAS ADVANCED. A SMALL LUMP WAS NOTICED MEDIAL TO THE PUNCTURE SITE. DEPLOYMENT WAS COMPLETED AND THE PT WAS DISCHARGED. THE NEXT DAY, THE PT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PAIN AROUND THE PUNCTURE SITE. A SMALL PSEUDOANEURYSM WAS IDENTIFIED USING ARTERIAL DUPLEX ULTRASOUND AND WAS SHOWN TO BE ABOUT 50 PERCENT THROMBOSED. THE PT'S CLOPIDOGREL MEDICATION WAS CEASED, AND THE PT WAS DISCHARGED THE NEXT DAY. OUTPATIENT ARTERIAL DUPLEX ULTRASOUND WILL BE PERFORMED TO DETERMINE IF FURTHER INTERVENTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3717380

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention