BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2080539 · Received April 22, 2011

    Report

    Report Number
    2182269-2011-00069
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    April 6, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. 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 OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATE THAT IF COLLAGEN DEPOSITION INTO THE ARTERY OR THROMBOSIS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011, FOLLOWING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH A SMART STENT PLACEMENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA AN ANTEGRADE APPROACH, A 6F ANGIO-SEAL STS PLUS WAS SELECTED FOR CLOSURE. A 6F RADIFOCUS SHEATH WAS ALSO USED DURING THE PROCEDURE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED A RIGHT COMMON FEMORAL ARTERY PUNCTURE WITH NO CALCIFICATION. THE LUMEN DIAMETER OF THE PUNCTURED ARTERY WAS 6.0MM. IT WAS ALSO NOTED PRIOR TO DEPLOYMENT, STENOSIS WAS FOUND AROUND THE PUNCTURE SITE. AFTER ANGIO-SEAL DEPLOYMENT, BLEEDING AT THE PUNCTURE SITE WAS OBSERVED. MANUAL COMPRESSION WAS APPLIED FOR FIFTEEN MINUTES AND HEMOSTASIS WAS ACHIEVED. ON (B)(6) 2011, THE PT REPORTED A COLD LEG. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED THROMBUS FORMATION AT THE PUNCTURE SITE. A FOGARTY CATHETER WAS USED TO HELP ELIMINATE THE THROMBUS FORMATION AND THE ANGIO-SEAL WAS SURGICALLY REMOVED. SURGICAL FINDINGS REVEALED THAT THE COLLAGEN WAS INSIDE THE VESSEL. ON (B)(6) 2011, THE PT WAS REPORTED TO BE RECOVERING AND ON BED REST. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 3251333

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R