BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 917653 · Received September 24, 2007

    Report

    Report Number
    2182269-2007-00277
    Event Type
    Injury
    Date Received
    September 24, 2007
    Date of Event
    August 22, 2007
    Report Date
    September 10, 2007
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ANCHOR, CONSISTENT WITH THAT USED IN THE 6F ANGIO-SEAL STS PLUS DEVICE, WAS VISUALLY INSPECTED. NO OTHER COMPONENTS WERE RETURNED. THE ANCHOR WAS DEFORMED, CONSISTENT WITH THE APPLICATION OF TENSILE AND/OR COMPRESSIVE FORCES AND EXPOSURE TO HEAL AND/OR MOISTURE. THE ANCHOR THROUGH-HOLE WAS INTACT. NO OTHER CONTRIBUTING ANOMALIES WERE NOTED. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THESE THREE LOTS (2012527, 2020962, AND 2021642) MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE MANUFACTURING AND EXPIRATION DATES ARE AS FOLLOWS: 2012527 MANUFACTURING DATE, 04-2007, USE BY DATE, 04-2008. 2020962 MANUFACTURING DATE, 05-2007, USE BY DATE, 05-2008. 2021642 MANUFACTURING DATE, 05-2007, USE BY DATE, 05-2008.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS PROCEDURE, AN 8F ANGIO SEAL STS PLUS WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. THE PATIENT REMAINED ON BEDREST FOR 2 HOURS. THREE HOURS AFTER THE PROCEDURE A HEMATOMA DEVELOPED. AN ULTRASOUND WAS PERFORMED AND CONFIRMED THE HEMATOMA WAS NOT A PSEUDOANEURYSM. MANUAL COMPRESSION WAS APPLIED FOR 1 HOUR AND THE PATIENT RECEIVED 2 UNITS OF BLOOD. HEMOSTASIS WAS ACHIEVED. THE NEXT DAY, THE PATIENT BEGAN REHAB CONSISTING OF KNEE BENDING; HOWEVER, THE PATIENT COULD NOT MOVE HIS/HER LEGS. TWO DAYS AFTER THE INITIAL PROCEDURE, REBLEEDING OCCURRED AND WAS DISCOVERED AFTER THE PATIENT'S LEG WAS FOUND TO BE SWOLLEN. THE PATIENT WENT INTO SHOCK, THE PATIENT UNDERWENT EMERGENCY SURGERY, WHERE THE PUNCTURE SITE WAS INCISED AND A PSEUDOANEURYSM WAS PRESENT. THE BEND ANCHOR WAS FOUND WITHIN THE PSEUDOANEURYSM; BOTH THE ANCHOR AND THE COLLAGEN WERE NOT ON THE SUTURE. THE COLLAGEN WAS STUCK ON THE VESSEL WALL. THE PATIENT RECEIVED 4 UNITS OF BLOOD. THE PHYSICIAN SUSPECTED OVER TAMPING OCCURRED AS FIRM TENSION WAS APPLIED TO FULLY EXPOSE THE COMPACTION MARKER FOLLOWED BY STRONG PRESSURE ON THE SUTURE KNOT WITH THE TAMP TUBE. ALLEGEDLY, THIS TECHNIQUE CAUSED ANCHOR DEFORMATION AND COLLAGEN BREAKAGE. THE PHYSICIAN FURTHER ALLEGED THAT BECAUSE OF THE ANCHOR DEFORMATION, THE ANCHOR POPPED OUT OF THE VESSEL INTO THE PSEUDOANEURYSM AND HEMOSTASIS WAS NOT MAINTAINED. THE DEVICE WAS FROM ONE OF THESE 3 LOTS 2012527, 2020962, AND 2021642.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 8F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 2012527 OR 2020962

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention