BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANCURE EXPANDABLE SHEATH

    MDR report key: 344476 · Received July 30, 2001

    Report

    Report Number
    2954310-2001-03670
    Event Type
    Other
    Date Received
    July 30, 2001
    Date of Event
    January 5, 2000
    Report Date
    July 20, 2001
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    DRE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SHEATH TORE DUE TO TORTUOUS ILIAC ARTERIES. THE PT RUPTURED ON THE TABLE AND WAS CONVERTED TO SOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34197 ANCURE EXPANDABLE SHEATH ENDOVASCULAR GRAFT SYSTEM ACCESSORY DRE GUIDANT ENDOVASCULAR SOLUTIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other