BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHECK-FLO PERFORMER INTRODUCER SET

    MDR report key: 353670 · Received October 1, 2001

    Report

    Report Number
    1820334-2001-00081
    Event Type
    Other
    Date Received
    October 1, 2001
    Date of Event
    September 5, 2001
    Report Date
    September 6, 2001
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED TO PUT THE ANEURX DEVICE THROUGH THE SHEATH. IT WAS EXTREMELY TIGHT, BUT THEY PUSHED THE DEVICE THROUGH THE SHEATH. WHEN THEY PULLED OUT THE DEVICE, THE SHEATH WAS LEAKING PROFUSELY. IT APPEARED THE VALVE WAS BROKEN AND A PORTION OF IT WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44334 CHECK-FLO PERFORMER INTRODUCER SET SHEATH SET DYB COOK INCORPORATED NA 1073646

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other