BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCURE EXPANDABLE SHEATH

    MDR report key: 344907 · Received July 30, 2001

    Report

    Report Number
    2954310-2001-03743
    Event Type
    Malfunction
    Date Received
    July 30, 2001
    Date of Event
    October 17, 2000
    Report Date
    July 27, 2001
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (2) 25CM SHEATHS. COULD NOT ADVANCE THE INNER DILATOR. REFER TO FILE # 00-2221, INCIDENT # 23650 FOR THE FIRST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34256 ANCURE EXPANDABLE SHEATH ENDOVASCULAR GRAFT SYSTEM MIH GUIDANT ENDOVASCULAR SOLUTIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN