BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1053318 · Received May 27, 2008

    Report

    Report Number
    3003681312-2008-00051
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 19, 2008
    Report Date
    May 2, 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
    UK
    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 RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. 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 DEVICE INSTRUCTIONS FOR USE (IFU) STATE 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 DEVICE INSTRUCTIONS FOR USE (IFU) CAUTION THAT AN AV FISTULA OR PSEUDOANEURYSM ARE POSSIBLE RISKS OR SITUATIONS ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A DIAGNOSTIC ANGIOGRAPHIC PROCEDURE, A SATISFACTORY PRE-INSERTION ANGIOGRAM WAS PERFORMED. THE ANGIOGRAPHIC PROCEDURE WAS WITHOUT COMPLICATION WITH A STRAIGHT FORWARD SINGLE WALL PUNCTURE. A 6F ANGIO-SEAL VIP DEVICE WAS DEPLOYED. THE ANGIO-SEAL DEPLOYMENT WAS STRAIGHT FORWARD, ACHIEVING INSTANT HEMOSTASIS. THE NEXT MORNING, THE PT REPORTED THAT WHEN USING THE TOILET AND GETTING UP, A "TWIST" AT THE ACCESS SITE WAS FELT AND THAT VERY QUICKLY A LUMP DEVELOPED AT THE SITE. THE PT APPLIED MANUAL PRESSURE OVER THE SITE AND THEN REPORTED BACK TO THE CARDIAC CATHETER LAB. THE LUMP WAS SUSPECTED TO BE A SMALL HEMATOMA, AND WAS DEALT WITH ACCORDINGLY. THE PT CONTINUES TO EXPERIENCE PAIN AND IS LIMPING. THE PHYSICIAN REPORTED THE HEMATOMA WAS NOW "MEDIUM" RATHER THAN "SMALL." AN ULTRASOUND REVEALED A PSEUDOANEURYSM. A THROMBIN INJECTION WAS PERFORMED AND THE PT IS REPORTED TO BE DOING WELL. THE SALES REP FOLLOWED UP WITH THE PHYSICIAN REGARDING ANGIO-SEAL VIP DEPLOYMENT TECHNIQUE AND FURTHER TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 2056264

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other