BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 3932074 · Received June 20, 2014

    Report

    Report Number
    3003681312-2014-00047
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL
    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

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MFG AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECS AND PROCEDURES. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE FOLLOWING A CORONARY ANGIOGRAM ON (B)(6) 2014. THE ACCESS PUNCTURE OF THE RIGHT FEMORAL ARTERY WAS CONSIDERED TO BE A HIGH STICK. THE PT WAS TRANSFERRED TO ANOTHER FACILITY AND CONTINUED TO RECEIVED CLEXANE AS THE PT WAS STILL IN ATRIAL FLUTTER AND WAS AMBULATING WITHOUT ANY COMPLICATIONS. THE PT AWAKENED WITH GROIN PAIN ON (B)(6) 2014, RETURNED TO THE HOSPITAL, AND WAS DIAGNOSED WITH RETROPERITONEAL BLEEDING. A PERCUTANEOUS COIL PROCEDURE WITH A STENT GRAFT OF THE COMMON FEMORAL ARTERY WAS PERFORMED TO RESOLVE THE CONDITION. THE PT RECEIVED A TRANSFUSION OF 7 UNITS OF BLOOD DURING THE PROCEDURE AND WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362447 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL 610132 4317384

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R