BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2202174 · Received August 4, 2011

    Report

    Report Number
    3003681312-2011-00056
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2009
    Report Date
    August 4, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION 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. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) INSTRUCTS THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE THE FEMORAL ARTERY CHARACTERISTICS PRIOR TO PLACING THE ANGIO-SEAL DEVICE BY INJECTING CONTRAST MEDIUM THROUGH THE PROCEDURE SHEATH AND USING FLUOROSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ANGIO-SEAL WAS SELECTED FOR USE. SOMETIME AFTER DEPLOYMENT, A PSEUDOANEURYSM, TWO CENTIMETER IS DIAMETER, DEVELOPED AT THE LEVEL OF THE ACCESS SITE. THE PSEUDOANEURYSM COMPRESSED THE VENOUS SYSTEM AND COMMON FEMORAL VEIN THROMBOSIS DEVELOPED. THE PSEUDOANEURYSM WAS TREATED WITH ULTRASOUND GUIDED THROMBIN INJECTION AND THE VENOUS THROMBOSIS WAS TREATED WITH ORAL ANTICOAGULATION MEDICATION. THE PATIENT WAS GIVEN ANTI-PLATELET AND ANTICOAGULATION MEDICATION (DOSES UNKNOWN), AND HOSPITALIZATION WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 2806948

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R