BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE MEDICAL

    MDR report key: 571293 · Received December 15, 2004

    Report

    Report Number
    571293
    Event Type
    Death
    Date Received
    December 15, 2004
    Date of Event
    December 7, 2004
    Report Date
    December 14, 2004
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT EXPIRED AFTER RETRO PERITONEAL BLEED. IN 2004 HAD ANGIOSEAL TO RIGHT GROIN AFTER CATH AT ANOTHER FACILITY. THREE DAYS LATER HAD ANGIOSEAL TO RIGHT GROIN AFTER A CYPHER STENT AT REPORTING FACILITY. IMAGING STUDY DONE 1ST TO ASSURE LOCATION APPROPRIATE. ONCE BLED STAFF DID NOT GET CONTROL OF GROIN TO STOP BLEEDING. UNK IF DEVICE (ANGIOSEALS) PLAYED ANY ROLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL ANGIOSEAL STS PLUS VASCULAR CLOSURE DEVICE MGB ST JUDE MEDICAL 610121 1097091

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death REOPRO| ANGIOMAX IN CCL