BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 2844447 · Received November 16, 2012

    Report

    Report Number
    2182269-2012-00122
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WAS NOT RETURNED, OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MFG AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER TO OBSERVE STERILE TECHNIQUE AT ALL TIMES WHEN USING THE DEVICE. THE USE OF THE DEVICE WHERE BACTERIAL CONTAMINATION OF THE PROCEDURE SHEATH OR SURROUNDING TISSUES MAY HAVE OCCURRED MAY CAUSE INFECTION. ANY SIGN OF INFECTION AT THE PUNCTURE SITE SHOULD BE TAKEN SERIOUSLY AND THE PT MONITORED CAREFULLY. SURGICAL REMOVAL OF THE DEVICE SHOULD BE CONSIDERED WHENEVER AN ACCESS SITE INFECTION IS SUSPECTED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT THE ANGIO-SEAL KIT IS SUPPLIED STERILE IN A POLY BAG. THE BAG INCLUDES A SEALED TRAY CONTAINING THE ANGIO-SEAL COMPONENTS. THE ANGIO-SEAL IS LABELED STERILE. THE ANGIO-SEAL DEVICE PT¿S INFO GUIDE, WHICH THE PT IS INSTRUCTED TO CARRY WITH THEM FOR 90 DAYS INSTRUCTS THE PT TO REMOVE THE DRESSING AFTER 24 HOURS AND CLEAN THE AREA WITH MILD SOAP AND WATER AND DRY THE AREA. THE SITE SHOULD BE COVERED WITH A BANDAGE AND CHANGED DAILY OR IF IT BECOMES WET, UNTIL THE SKIN HEALS. THE PT IS ALSO INSTRUCTED TO CONTACT THE PHYSICIAN IMMEDIATELY IF THEY DEVELOP A FEVER, PERSISTENT TENDERNESS IN THE GROIN OR SWELLING, WOUND DRAINAGE, OR REDNESS AND/OR WARMTH AT THE SITE.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL EVOLUTION WAS SELECTED FOR USE AND DEPLOYED, FOLLOWING A DIAGNOSTIC CARDIAC ANGIOGRAM. THE PT WAS DISCHARGED FROM HOSPITAL, BUT PRESENTED BACK WITH GROIN PAIN, SWELLING, AND SUSPECTED INFECTION. THE PT WAS ADMINISTERED ANTIBIOTICS (UNKNOWN TYPE/DOSE/STRENGTH) AND DISCHARGED, BUT PRESENTED AGAIN TWO DAYS LATER DUE TO GROIN PAIN. ADD¿L INFO WAS REQUESTED BUT NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA 3721354

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention