BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGO-SEAL DEVICE VIP

    MDR report key: 1033719 · Received April 25, 2008

    Report

    Report Number
    2182269-2008-00115
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 29, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT 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 IFU STATES POTENTIAL ADVERSE REACTIONS OR CONDITIONS MAY BE ASSOCIATED WITH ONE OR MORE ANGIO-SEAL DEVICE COMPONENTS (I.E., COLLAGEN, SYNTHETIC ABSORBABLE SUTURE, AND/OR POLYMER). THESE INCLUDE ALLERGIC REACTION, FOREIGN BODY REACTION, POTENTIATION OF INFECTION, INFLAMMATION AND EDEMA. THE IFU STATES THE ANGIO-SEAL KIT IS SUPPLIED STERILE IN POLY BAG. THE BAG INCLUDES A SEALED TRAY CONTAINING THE ANGIO-SEAL COMPONENTS. THE ANGIO-SEAL IS LABELED STERILE. THE ANGIO-SEAL PT INFO GUIDE 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 BAND-AID 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, PERSISTANT TENDERNESS IN THE GROIN OR SWELLING, WOULD DRAINAGE, OR REDNESS AND/OR WARMTH AT THE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS ANGIOGRAM AN ANGIO-SEAL VIP WAS USED. NO PROBLEMS WERE EXPERIENCED WITH THE DEPLOYMENT OR THE PROCEDURE. THE PT WAS DISCHARGED LATER THAT DAY. FOUR DAYS LATER, THE PT WAS ADMITTED TO THE HOSPITAL WITH A GROIN INFECTION. THE INFECTION WAS DIAGNOSED AS METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) BACTEREMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGO-SEAL DEVICE VIP ANGIO-SEAL DEVICE VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention