BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1111012 · Received August 11, 2008

    Report

    Report Number
    3003681312-2008-00082
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    June 7, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    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 FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION 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 PATIENT MONITORED CAREFULLY. SURGICAL REMOVAL OF THE DEVICE SHOULD BE CONSIDERED WHENEVER AN ACCESS SITE INFECTION IS SUSPECTED. THE ANGIO-SEAL 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 ANGIO-SEAL IFU STATES 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 PATIENT INFORMATION GUIDE INSTRUCTS THE PATIENT 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-AGE AND CHANGED DAILY OR IF IT BECOMES WET, UNTIL THE SKIN HEALS. THE PATIENT 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

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS PROCEDURE, AN ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED MODERATE CALCIFICATION AT THE PUNCTURE SITE. THE ANGIO-SEAL WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. FOUR HOURS LATER, THE PATIENT AMBULATED. EIGHT DAYS AFTER THE PROCEDURE, THE PATIENT WAS DISCHARGED HOME. THREE WEEKS LATER AFTER THE PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH AN INFECTION. A CRP BLOOD CULTURE LEVEL WAS INCREASED TO ABOUT 20. ANTIBIOTICS HAVE BEEN GIVEN TO THE PATIENT TO CONTROL THE INFECTION. A SYNTHETIC GRAFT IS BEING PLANNED. SJM PRODUCT SURVEILLANCE WAS MADE AWARE OF THE EVENT IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 2056244

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| O