BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1212203 · Received October 16, 2008

    Report

    Report Number
    3003681312-2008-00099
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    August 7, 2008
    Report Date
    October 16, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO REC'D, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR 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. IF NECESSARY, MONITOR PEDAL PULSES. THE IFU CAUTIONS THAT IF THE PUNCTURE SITE IS AT OR DISTAL TO THE BIFURCATION OF THE SUPERFICIAL FEMORAL AND PROFUNDA FEMORIS ARTERY, AS THIS MAY RESULT IN THE ANGIO-SEAL DEVICE ANCHOR CATCHING ON THE BIFURCATION OR BEING POSITIONED INCORRECTLY, AND/OR CALLOGEN DEPOSITION IN THE VESSEL. THESE EVENTS MAY REDUCE BLOOD FLOW THROUGH THE VESSEL LEADING TO SYMPTOMS OF DISTAL ARTERIAL INSUFFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS CARDIOLOGY PROCEDURE, THAT THE CARDIOLOGIST DECIDED TO USE AN ANGIO-SEAL, DUE TO THE PT'S ELEVATED INR. A PREDEPLOYMENT SHEATHOGRAM INDICATED THAT THE SHEATH WAS BELOW THE BIFURCATION OF THE FEMORAL ARTERY, AND THAT THE VESSEL WAS LARGE ENOUGH TO USE AN ANGIO-SEAL. THE PHYSICIAN HAD BEEN TRAINED IN THE USE OF THE DEVICE, BUT HAD NOT USED ONE IN SOMETIME. DURING DEPLOYMENT, THE PHYSICIAN HAD DIFFICULTIES GETTING THE COLLAGEN PLUG TO DEPLOY. THE COLLAGEN WOULD NOT ADVANCE INTO THE ARTERIOTMY TRACT AND THE DEVICE WOULD NOT PULL BACK OUT OF THE SHEATH. A RESERVOIR WAS FASHIONED TO CATCH BLOOD SO THAT THE AMOUNT LOST COULD BE RECORDED. THE ENTIRE DEVICE WAS SUTURED TO THE PT AND THE PT WAS RETURNED TO THE FLOOR. AT SOME POINT THE CARDIOLOGIST SPOKE WITH THE SURGEON AND THE PT UNDERWENT SURGICAL INTERVENTION. THE ANGIO-SEAL WAS REMOVED.

    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 2152749

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R