BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS

    MDR report key: 513588 · Received February 27, 2004

    Report

    Report Number
    2182269-2004-00024
    Event Type
    Injury
    Date Received
    February 27, 2004
    Date of Event
    October 28, 2003
    Report Date
    February 27, 2004
    Manufacturer
    ST. JUDE MEDICAL, DAIG DIVISION, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003, THE PT UNDERWENT A CARDIAC CATHETERIZATION WHICH REVEALED A 50-70% OCCLUSION IN THE LEFT CORONARY ARTERY, 100% OCCLUDED LEFT ANTERIOR DESCENDING ARTERY, 70% OCCLUSION IN THE CIRCUMFLEX ARTERY, AND A 100% OCCLUDED RIGHT CORONARY ARTERY. AN ANGIO-SEAL DEVICE WAS DEPLOYED TO SEAL THE ARTERIOTOMY SITE. DURING TRANSFER TO THE RECOVERY ROOM, THE PT COMPLAINED OF RIGHT LEG CRAMPING, IT WAS NOTED THE RIGHT PEDAL PULSE WAS ABSENT BY PALPATION AND CONFIRMED ABSENT WITH A DOPPLER; THE RIGHT LEG WAS COOL. A FAINT RIGHT POPLITEAL PULSE WAS PRESENT; THE RIGHT AND LEFT FEMORAL PULSES WERE PALPABLE. UNDER LARYNGEAL MASK ANESTHESIA, THE PT UNDERWENT EXPLORATORY SURGERY. AFTER LOCAL INFILTRATION, AND INCISION WAS MADE OVER THE RIGHT FEMORAL PULSE; THE FEMORAL ARTERY WAS IDENTIFIED. THE ANGIO-SEAL DEVICE WAS LOCATED JUST ABOVE THE BIFURCATION OF THE PROFUNDA AND THE SUPERFICIAL FEMORAL ARTERIES; A DOPPLER SIGNAL WAS OBTAINED FROM THE SUPERFICIAL FEMORAL ARTERY. AN ADD'L HEPARIN 2,000 UNITS WERE GIVEN; THE ANGIO-SEAL DEVICE WAS REMOVED. A FOGARTY CATHETER WAS PLACED IN THE PROXIMAL COMMON FEMORAL ARTERY; NO THROMBUS WAS REMOVED AND ARTERIAL INFLOW WAS OBTAINED. A FOGARTY CATHETER WAS PLACED IN THE SUPERFICIAL FEMORAL ARTERY; A MODERATE AMOUNT OF THROMBUS WAS REMOVED. THE ARTERIOTOMY WAS CLOSED WITH BACKFLOW OBTAINED FROM THE PROFUNDA AND THE SUPERFICIAL FEMORAL ARTERIES. AT THIS TIME, PEDAL PULSE WERE PALPABLE. HEMOSTASIS WAS ACHIEVED AND THE WOUND CLOSED. THE PT TOLERATED THE PROCEDURE WELL AND WITHOUT COMPLICATIONS. THE PT WAS REPORTEDLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS 8F ANGIO-SEAL STS MGB ST. JUDE MEDICAL, DAIG DIVISION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention THE PT RECEIVED HEPARIN 5,000 UNITS DURING THE| CARDIAC CATHETERIZATION PROCEDURE.