BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENTINOL

    MDR report key: 5479682 · Received May 31, 2005

    Report

    Report Number
    5479682
    Event Type
    Injury
    Date Received
    May 31, 2005
    Date of Event
    May 20, 2005
    Report Date
    May 26, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN ANGIO CATH LAB, DURING EXCHANGE OF SHEATH IN ABDOMINAL AORTA-GRAM WITH STENT PLACEMENT AND PTA, A PIECE OF STENT WAS NOTICED ON REMOVED SHEATH. A PIECE MIGRATED CAUSING BLEED AND NECESSITATING OPERATION ROOM FOR REMOVAL OF PIECE AND HEMOSTASIS. (RIGHT EXTERNAL ILIAC STENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTINOL BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC 7X59MM 6377471

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R