BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE

    MDR report key: 621943 · Received July 21, 2005

    Report

    Report Number
    2182269-2005-00139
    Event Type
    Injury
    Date Received
    July 21, 2005
    Date of Event
    June 29, 2005
    Report Date
    July 21, 2005
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS FROM THREE POSSIBLE LOT NUMBERS; 1144105, 1111822, & 1116178.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD INTERNAL BLEEDING THE MORNING AFTER A SUCCESSFUL DEPLOYMENT OF A 6F ANGIO-SEAL MP DEVICE POST PERCUTANEOUS CORONARY INTERVENTION. THE ABDOMINAL BLEEDING WAS CONFIRMED BY A CT SCAN AND THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SURGICAL REPAIR. UPON ARRIVAL TO THE HOSPITAL, THE DOCTOR FOUND NO BLEEDING IN THE GROIN AREA, THE FEMORAL PULSE WAS PALPABLE AND NO SWELLING OF THE ABDOMEN; THE DOCTOR POSTPONED THE SURGERY. LATER IN THE DAY ABDOMINAL SWELLING OCCURRED AND THE PT UNDERWENT SURGERY. THE SURGEON STATED THE SUPERIOR WALL PUNCTURE OF THE FEMORAL ARTERY WAS HIGHER AND UNDER THE INGUINAL LIGAMENT, BUT THE POSTERIOR WALL WAS NOT PUNCTURED. BLOOD WAS SEEN FLOWING INTO THE ABDOMEN AND THE ANGIO-SEAL WAS NOT IDENTIFIED. THE FEMORAL ARTERY WAS SUTURED, A DRAIN WAS INSERTED FOR ASPIRATION, THE PROCEDURE WAS COMPLETED, AND THE PT RETURNED TO THE WARD. SOMETIME LATER, THE ABDOMINAL BLEEDING REOCCURRED AND THE PT EXPERIENCED ATRIAL FIBRILLATION. WHILE PREPARING THE PT FOR A PACEMAKER, THE PT EXPIRED. THE PHYSICIAN STATED THE BLEEDING FROM THE FEMORAL ARTERY MAY HAVE RESULTED FROM INCOMPLETE HEMOSTASIS OF THE ANGIO-SEAL, HOWEVER THE PT'S DEATH IS NOT RELATED TO THE ANGIO-SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE 6F ANGIO-SEAL MILLENNIUM MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention