BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 118124 · Received September 3, 1997

    Report

    Report Number
    2242352-1997-00072
    Event Type
    Malfunction
    Date Received
    September 3, 1997
    Date of Event
    August 11, 1997
    Report Date
    August 12, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    MAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE GRAFT WAS IMPLANTED FOR AN AORTO-BIFEMORAL PROCEDURE. AFTER THE PROXIMAL ANASTOMOSIS AND UNCLAMPING, THE GRAFT LEAKED AN UNKNOWN QUANTITY OF BLOOD THROUGHOUT ITS WALLS. THE BLEEDING STOPPED AFTER A FEW MINUTES. SOME ADD'L BLEEDING THROUGH A HOLE IN ITS WALL PROXIMAL TO THE BIFURCATION WAS STOPPED WITH A PATCH. THE QUANTITY OF BLOOD LOST THROUGH THE GRAFT IS UNKNOWN. THE GRAFT WAS LEFT IN. THERE WAS NO PT INJURY. THE PT'S POST-OP CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT MAL MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 085168 616152

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO