BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 1970135 · Received January 13, 2011

    Report

    Report Number
    2182269-2011-00003
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 13, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 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 INSTRUCTIONS FOR USE (IFU) PRECAUTIONS STATE THAT A SINGLE WALL PUNCTURE TECHNIQUE SHOULD BE USED. THE POSTERIOR WALL OF THE ARTERY SHOULD NOT BE PUNCTURED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) INSTRUCTS THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE THE FEMORAL ARTERY CHARACTERISTICS PRIOR TO PLACING THE ANGIO-SEAL DEVICE BY INJECTING CONTRAST MEDIUM THROUGH THE PROCEDURE SHEATH AND USING FLUOROSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL WAS SELECTED FOR CLOSURE IN THE LEFT FEMORAL ARTERY. APPROXIMATELY TWO HOURS AFTER THE PROCEDURE, THE PATIENT GOT UP FROM BED REST AND BLEEDING AT THE PUNCTURE SITE WAS OBSERVED AFTER THE PATIENT BENT OVER TO TIE HIS SHOES. A PRESSURE BANDAGE WAS PLACED ON THE PUNCTURE SITE AND MANUAL COMPRESSION ALSO HAD TO BE APPLIED FOR TEN MINUTES TO CONTROL THE BLEEDING. THE PATIENT'S STAY IN THE HOSPITAL WAS EXTENDED FOR FURTHER MONITORING. AN ULTRASOUND WAS PERFORMED TO SEE IF THE ANCHOR WAS STILL IN PLACE AND THE RESULTS OF THE ULTRASOUND ARE UNKNOWN. THE PATIENT WAS REPORTED TO BE STABLE AND THERE WERE NO ADDITIONAL REPORTED CONSEQUENCES NOTED. IT WAS ALSO NOTED THAT THE POSTERIOR WALL OF THE LEFT FEMORAL ARTERY WAS PUNCTURED. THE PATIENT WAS TAKING PRESCRIBED MEDICATIONS: ASPIRIN (DOSAGE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 3182228

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R