BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 2080536 · Received April 22, 2011

    Report

    Report Number
    2182269-2011-00072
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES. 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. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES THAT A SINGLE WALL PUNCTURE TECHNIQUE SHOULD BE USED. THE POSTERIOR WALL OF THE ARTERY SHOULD NOT BE PUNCTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO EVOLUTION WAS DEPLOYED IN THE RIGHT COMMON FEMORAL ARTERIOTOMY (RCFA), AFTER A PERCUTANEOUS CORONARY INTERVENTION (PCI). THE ANGIO-SEAL WAS SUCCESSFULLY DEPLOYED WITH HEMOSTASIS BEING ACHIEVED. A FEW HOURS AFTER THE PROCEDURE, THE PT DEVELOPED RETROPERITONEAL BLEEDING. A CT SCAN AND ULTRASOUND DIAGNOSED THE BLEEDING. MANUAL COMPRESSION WAS APPLIED TO THE GROIN AND THE PT RECEIVED A BLOOD TRANSFUSION (AMOUNT UNK). THE PT'S HOSPITALIZATION WAS EXTENDED; HOWEVER, AFTER THE MANUAL COMPRESSION, THE PT WAS REPORTED TO BE STABLE. THE PT WAS DISCHARGED FROM THE HOSPITAL (DATE UNK). THE HOSPITAL STAFF DO NOT BELIEVE THAT THE BLEEDING WAS CAUSED BY THE ANGIO-SEAL DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL EVOLUTION MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R THE PT WAS TAKING CLOPIDIGREL (DOSE UNK).