BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2100801 · Received May 19, 2011

    Report

    Report Number
    2182269-2011-00088
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 18, 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 MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO 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 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 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 PT INFO GUIDE STATE SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURES; HOWEVER, THE PT SHOULD CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THE PT INFO CARD IF THEY EXPERIENCE FEVER, BLEEDING, PERSISTENT SWELLING IN THE GROIN OR SWELLING, REDNESS AND/OR WARM TO TOUCH, NUMBNESS, TINGLING OR PAIN IN THE EXTREMITY WHEN AMBULATING, RASH, WOUND DRAINAGE OR ANY OTHER UNUSUAL SYMPTOMS. 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, 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 ON (B)(6) 2011 FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A CTO LESION AND AN ANGIO-SEAL STS PLUS WAS DEPLOYED VIA THE LEFT COMMON FEMORAL ARTERIOTOMY. THE PT WAS RELEASED FROM BED REST AND AMBULATED AFTER APPROX 6 HOURS AFTER DEPLOYMENT. THE FOLLOWING DAY, THE PT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6)2011, THE PT RETURNED TO THE HOSPITAL REPORTING PAIN. THE PT WAS DIAGNOSED WITH AN INFECTION. THE PT HAD A FEVER, HEAT SENSATION WAS PRESENT, AND A SMALL HEMATOMA HAD ALSO FORMED AT THE PUNCTURE SITE. ON (B)(6) 2011, THE PT WAS DISCHARGED FROM HOSPITAL WITH A FOLLOW-UP APPOINTMENT SCHEDULED FOR (B)(6) 2011. NO FURTHER INFO IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA 3244886

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R ROCEPHIN (1.0G/DAY) AND| PAIN RELIEF MEDICATION WAS ALSO PRESCRIBED| (TYPE AND DOSAGE UNKNOWN).| DALACIN S (1200MG/DAY),| THE PATIENT WAS TREATED WITH ANTIBIOTICS,