BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIO-SEAL DEVICE STS PLUS PLATFORM

    MDR report key: 1656770 · Received April 8, 2010

    Report

    Report Number
    2182269-2010-00065
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    March 19, 2010
    Report Date
    April 8, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, SURGICAL FINDINGS REPORTED AN ARTERIAL DISSECTION WHICH IS A KNOWN VASCULAR COMPLICATION THAT RESULTS FROM ARTERIAL ACCESS INTO THE ARTERY. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A HEART CATHETERIZATION WAS PERFORMED. AN INITIAL PUNCTURE WAS MADE FOR RADIAL ACCESS AND THE HEART CATHETERIZATION PROCEEDED. RADIAL SPASM FORCED THE PROCEDURE TO MOVE TO A FEMORAL APPROACH. AFTER FEMORAL ACCESS, THE HEART CATHETERIZATION CONTINUED AS THE RIGHT CORONARY ARTERY WAS EVALUATED AND THE PROCEDURE COMPLETED. THE PATIENT HAD MULTIPLE VESSEL STENOSIS AND CARDIAC SURGERY WAS PLANNED FOR TREATMENT. A PRE-INSERTION ANGIOGRAM OF THE COMMON FEMORAL ARTERY WAS PERFORMED AND AN ANGIO-SEAL STS PLUS WAS SELECTED FOR USE AFTER VERIFICATION OF CALCIFICATION, BIFURCATION OF VESSELS, VESSEL SIZE, AND SINGLE WALL PUNCTURE. AFTER PLACING THE ANGIO-SEAL AND REMOVING THE TAMPER TUBE ARTERIAL BLEEDING OCCURRED. MANUAL COMPRESSION WAS APPLIED FOR 15 MINUTES FOLLOWED BY A COMPRESSION BANDAGE, PERIPHERAL PULSES WERE CHECKED AND THE PATIENT WAS RETURNED TO THE NURSING FLOOR. THREE HOURS AND 30 MINUTES LATER, ARTERIAL BLEEDING OCCURRED AT THE PUNCTURE SITE AND MANUAL COMPRESSION WAS APPLIED. THE PHYSICIAN CONSULTED VASCULAR SURGERY AND THE PATIENT UNDERWENT SURGERY FOR FEMORAL ARTERY EXPLORATION AND REPAIR. THE SURGEON REPORTED THE PRESENCE OF A DISSECTION IN THE ARTERIAL WALL WHERE THE ANGIO-SEAL WAS LOCATED. AFTER SURGERY, THE PATIENT'S FEMORAL ARTERY STARTED BLEEDING AND MANUAL COMPRESSION WAS APPLIED. DURING THE MANUAL COMPRESSION OF THE FEMORAL ARTERY, THE PATIENT SUFFERED A CORONARY INFARCTION AND DIED. THE PHYSICIANS ALLEGE THIS INFARCTION OCCURRED DUE TO EXCESSIVE STRESS FOR THE PATIENT CAUSED FROM SURGERY AND THE BLEEDING EVENTS. THE PATIENT HAD A MEDICAL HISTORY OF CORONARY ARTERY DISEASE AND ALCOHOL ABUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL DEVICE STS PLUS PLATFORM ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| R