BEUDAMED
    FDA Adverse Event Other Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 2896602 · Received December 28, 2012

    Report

    Report Number
    2182269-2012-00151
    Event Type
    Other
    Date Received
    December 28, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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) STATES THAT THE SAFETY AND EFFECTIVENESS OF THE ANGIO-SEAL DEVICE HAS NOT BEEN ESTABLISHED IN PATIENTS WITH UNCONTROLLED HYPERTENSION. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) INSTRUCTS THE USER NOT TO USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS PROXIMAL TO THE INGUINAL LIGAMENT AS THIS MAY RESULT IN A RETROPERITONEAL BLEED.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL EVOLUTION WAS SELECTED FOR USE. THE PATIENT WAS HYPERTENSIVE WITH A SYSTOLIC BLOOD PRESSURE >200HG, THROUGHOUT THE INTERVENTIONAL PROCEDURE. WHEN THE ANGIO-SEAL WAS DEPLOYED, IT FAILED TO ACHIEVE HEMOSTASIS. MANUAL COMPRESSION WAS HELD WHILE BLEEDING CONTINUED AND A HEMATOMA DEVELOPED. WHEN THE BLOOD PRESSURE NORMALIZED, HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH MANUAL COMPRESSION AND THE PATIENT WAS STABLE. THE PATIENT'S HOSPITALIZATION WAS EXTENDED TO RULE OUT A RETROPERITONEAL BLEED DUE TO POSSIBLE HIGH ACCESS PUNCTURE. COMPUTED TOMOGRAPHY RULED OUT A RETROPERITONEAL BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA 3782672

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization