BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1232165 · Received November 14, 2008

    Report

    Report Number
    2182269-2008-00251
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 13, 2008
    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, COLLAGEN, AND SUTURE SEGMENT, CONSISTENT WITH COMPONENTS USED IN THE ANGIO-SEAL DEVICE, WERE VISUALLY INSPECTED. THE ANCHOR LEGS WERE CURVED AWAY FROM THE ANCHOR DOME, CONSISTENT WITH EXPOSURE TO HEAT/MOISTURE AND EXTERNAL FORCES. THE ANCHOR AND COLLAGEN WERE SECURED BY THE INTACT SUTURE LOOP. THE COLLAGEN WAS REMOVED; NO CONTRIBUTING VISUAL ANOMALIES WERE NOTED. 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 FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING 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. IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES IN VERY THIN PATIENTS THE COLLAGEN MAY PROTRUDE FROM THE SKIN AFTER TAMPING HAS BEEN COMPLETED. ATTEMPT TO PUSH THE COLLAGEN UNDER THE SKIN USING THE TAMPER TUBE OR A STERILE HEMOSTAT. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES A COMPLETE SEAL IS INDICATED WHEN RESISTANCE IS FELT AND HEMOSTASIS IS ACHIEVED. AS A GUIDE, IN MOST CASES A BLACK COMPACTION MARKER WILL BE REVEALED. ONCE HEMOSTASIS IS ACHIEVED, DO NOT TAMP TO INTENTIONALLY GO BEYOND THE DISTAL END OF THE BLACK COMPACTION MARKER IN ORDER TO PREVENT ANCHOR DEFORMATION AND/OR COLLAGEN TEARING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE (PCI), AN ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. THE PATIENT WAS BEING TREATED FOR ISCHEMIC HEART DISEASE. A PRE-DEPLOYMENT ANGIOGRAM SHOWED MILD CALCIFICATION AT THE RIGHT COMMON FEMORAL ARTERY (CFA) PUNCTURE SITE. A 7F-25CM MEDIKIT SHEATH WAS ALSO USED. THE ANGIO-SEAL WAS DEPLOYED, BUT THE COLLAGEN PROTRUDED FROM THE SKIN AS THE PATIENT'S SUBCUTANEOUS TISSUE WAS THIN. THE PHYSICIAN GUIDED THE COLLAGEN UNDERNEATH THE SKIN WITH THE TAMPER TUBE. THE COMPACTION MARKER WAS FULLY EXPOSED AND THE PUNCTURE SITE WAS STILL BLEEDING. MANUAL COMPRESSION WAS APPLIED FOR TEN MINUTES, AND HEMOSTASIS WAS ACHIEVED. THE PATIENT RETURNED TO THEIR ROOM WITH A SAND BAG ON THE PUNCTURE SITE. TWO HOURS LATER, THE PATIENT EXPERIENCED BLEEDING AT THE PUNCTURE SITE AND MANUAL COMPRESSION WAS APPLIED FOR 100 MINUTES; HOWEVER, HEMOSTASIS WAS NOT ACHIEVED. SIX HOURS LATER, SURGERY WAS PERFORMED. THE ANCHOR, COLLAGEN AND SUTURE WERE REMOVED AND THE PUNCTURE SITE WAS SUTURED. THE REMOVED ANCHOR WAS FOUND TO BE BENT. THE PATIENT'S BLOOD PRESSURE DECREASED BEFORE AND DURING THE PROCEDURE REQUIRING MEDICATIONS TO MAINTAIN THE PATIENT'S BLOOD PRESSURE. THE PATIENT HAS RECOVERED. THE PATIENT WAS GIVEN ASPIRIN PRIOR TO THE PROCEDURE, AND PLAVIX A WEEK BEFORE THE PROCEDURE.

    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 2069751

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention THE PATIENT WAS TAKING PRESCRIBED ANTI-COAGULANTS| MEDICATION.