BEUDAMED
    FDA Adverse Event Death Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE

    MDR report key: 380149 · Received March 7, 2002

    Report

    Report Number
    72926-2002-00001
    Event Type
    Death
    Date Received
    March 7, 2002
    Date of Event
    February 4, 2002
    Report Date
    March 7, 2002
    Manufacturer
    ST. JUDE MEDICAL, P.R., B.V.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6F ANGIO-SEAL WAS DEPLOYED BY A CERTIFIED PHYSICIAN AT APPROX 4:30 PM FOLLOWING A HEART CATH PROCEDURE AND FEMORAL ANGIOGRAM. IT WAS PERCEIVED TO BE A "GOOD DEPLOYMENT". THE PT LEFT THE CATH LAB IN STABLE CONDITION AND THE GROIN PUNCTURE SITE APPEARED "IN NORMAL LIMITS". ON THE WARD, ROUTINE LABS WERE DRAWN THE FOLLOWING DAY AT 5AM WHICH SHOWED A SIGNIFICANT DROP IN HGB/HCT. PRIOR TO PROCEDURE HEMOGLOBIN WAS 11, AT 5AM HGB=8.4; HCT=26. A CT SCAN REVEALED A LARGE ABDOMINAL/INGUINAL HEMATOMA. IV FLUIDS, BLOOD PRODUCTS AND EMERGENCY MEASURES FAILED TO RESTABILIZE THE PT AND PT EXPIRED. THE PHYSICIAN DID NOT BELIEVE THAT THE ANGIO-SEAL DEVICE CONTRIBUTED TO THE PT'S RAPID DECLINE AND STATED THAT THE ARTERIOTOMY MAY HAVE BEEN A BACK WALL PUNCTURE.

    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, P.R., B.V. 610091 01DT70

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death ASPIRIN, LOVENOX (HELD 24 HOURS PRIOR TO| PROCEDURE).