BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1132403 · Received August 14, 2008

    Report

    Report Number
    1132403
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED FOR A RECURRING INFECTION. ON THE DAY OF DISCHARGE, THE PT BECAME SHORT OF BREATH AND DIAPHORETIC WITH CHEST PAIN. AN ECHOCARDIOGRAM SHOWED PULMONARY HYPERTENSION. A CARDIAC CATHETERIZATION REVEALED NO BLOCKAGE WITH NORMAL CORONARY ARTERIES. THE ANGIO-SEAL WAS DEPLOYED; HEMOSTASIS WAS ACHIEVED. THE PT WAS UNCOOPERATIVE AND WOULD NOT KEEP HIS LEG STRAIGHT AND STILL DURING THE PROCEDURE. THE PHYSICIAN INDICATED THAT HE WAS UNSURE IF THE DEVICE WAS DEPLOYED CORRECTLY DUE TO THE PT'S SIZE. THE PT'S RIGHT LEG FELT NUMB AND THE POPLITEAL ARTERY WAS NOT PALPABLE; A REPEAT ANGIOGRAM SHOWED THAT THE ANGIO-SEAL ANCHOR WAS NOT FLAT AGAINST THE ARTERIAL WALL. THE PT'S FEMORAL ARTERY WAS REPAIRED AND PULSES WERE RESTORED. THE SURGEON NOTED THAT THE ANCHOR WAS CAUGHT ON A PIECE OF PLAQUE. FOUR DAYS LATER, THE PT WAS DISCHARGED.

    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 2076408

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R