BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2161779 · Received July 7, 2011

    Report

    Report Number
    3003681312-2011-00049
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED A 6F SHEATH WAS USED TO ACCESS THE LEFT COMMON FEMORAL ARTERY VIA THE RIGHT COMMON FEMORAL ARTERY TO PERFORM AN ILIAC STENTING PROCEDURE. AN ANGIO-SEAL WAS USED FOR CLOSURE. THE PT RECEIVED 3000 UNITS OF HEPARIN DURING THE PROCEDURE. THE VESSEL WAS 4MM ABOVE THE BI-FURCATION AND BELOW THE INGUINAL LIGAMENT. SOME DISEASE AND CALCIUM BUILDUP WAS OBSERVED AND NOTED AT THE PUNCTURE SITE. DURING THE DEPLOYMENT, ALL THE STEPS WERE FOLLOWED. WHEN COMPACTING THE COLLAGEN, THERE WAS SOME TRACT RESISTANCE INITIALLY. POST DEPLOYMENT, THERE WAS TRACT OOZE, WHICH WAS CONTROLLED WITH LIGHT COMPRESSION THAT WAS PERFORMED FOR APPROX FIVE MINS AND HEMOSTASIS WAS ACHIEVED. THE PT WAS BROUGHT BACK DOWN TO THE CATH LAB LATER THAT AFTERNOON, DUE TO THE ABSENCE OF PEDAL PULSES AND LEG ISCHEMIA. AN ANGIOGRAM WAS PERFORMED, WHICH REVEALED RESTRICTED BLOOD FLOW. THE PHYSICIAN BALLOONED THE VESSEL WALL TO CLEAR THE LUMEN AND IMPROVE THE BLOOD FLOW. THE PT WS REPORTED TO BE STABLE AFTER THE PROCEDURE AND WAS LATER DISCHARGED FROM THE HOSPITAL. THE PHYSICIAN WAS ALSO GOING THROUGH THE ANGIO-SEAL CERTIFICATION PROCESS AND THIS WAS HIS SECOND DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3314603

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R